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Atopic DermatitisPhase 1NCT05383378

A First-In-Human Study to Evaluate the Safety, Tolerability, and Efficacy of Si-544 in Adults With Atopic Dermatitis

A Phase 1 study testing si-544 in people with Atopic Dermatitis, run by selectION Therapeutics GmbH at 5 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a multi-center, Phase 1b, double-blind, placebo-controlled, SAD and MAD, first-in-human study in subjects with mild to severe AD receiving si-544. The study consists of 2 parts, an SAD and an MAD part. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Atopic Dermatitis
What is being tested?
si-544
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
36 participants
Where
5 sitesGermany
Study dates
30 Aug 2022to 1 Nov 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • SAD and MAD part
  • Change (ie, starting anew, change in frequency, or change in drug substance) in standard systemic and topical therapy, or in immunosuppressive drug therapy within 4 weeks before Screening (for biologics such as dupilumab, the therapy may not be changed within 12 weeks before Screening), as judged by the investigator
  • Known history of hypersensitivity to constituents or excipients in the pharmaceutical formulation of the IMP
  • Uncontrolled hypertension or uncontrolled diabetes
  • History of seizures
  • Presence or history of paresthesia or neuropathy
Show all 22Show fewer
  • Clinically significant ECG abnormalities, as judged by the investigator
  • Clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine, renal, or other major systemic disease, as judged by the investigator
  • Presence of acute infection within 7 days before Screening, as judged by the investigator
  • Known or active infection with Mycobacterium tuberculosis
  • Known or active infection with human immunodeficiency virus, hepatitis B virus, or hepatitis C virus
  • Vaccination within 2 weeks before Screening and/or planned vaccination during the SAD part or the treatment period of the MAD part
  • Pregnancy
  • Any finding or medical condition prohibiting the inclusion in the study, as judged by the investigator
  • Current or previous (within 4 weeks before Screening) participation in another clinical study with an investigational medicinal product or medical device
  • Known or suspected abuse of alcohol, drugs, or medicinal products
  • Employee of the sponsor, or employee, or relative of the investigator
  • Use of prohibited medication
  • Subjects committed to an institution by virtue of an order issued either by the judicial or the administrative authorities
  • Legal incapacity or limited legal capacity
  • MAD part
  • Previous participation in the SAD part of this study with IMP dosing within 3 months before the planned first dosing of the MAD part.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Germany5 sites

  • selectION Clinical Trial Site

    Berlin

  • selectION Clinical Trial Site

    Hamburg

  • selectION Clinical Trial Site

    Magdeburg

  • selectION Clinical Trial Site

    Mainz

  • selectION Clinical Trial Site

    Wuppertal

Other trials in Germany

About this study

Official title: A Multi-center, Phase 1b, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Efficacy of Si-544 in Adults With Atopic Dermatitis

This is a multi-center, Phase 1b, double-blind, placebo-controlled, SAD and MAD, first-in-human study in subjects with mild to severe AD receiving si-544. The study consists of 2 parts, an SAD and an MAD part. In both parts, subjects will be treated in cohorts and will be randomized within each cohort to treatment with si-544 or placebo. Initially, 2 sentinel subjects will be treated (randomized to placebo or si-544) in each cohort.

Being tested
si-544, Placebo
Keywords
Atopic Eczema, Neurodermatitis
Medical subject headings
Dermatitis, Atopic, Neurodermatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • si-544Drug

    Subcutaneous injection in the abdomen

  • PlaceboDrug

    Subcutaneous injection in the abdomen

Study groups in NCT05383378
Study groupRoleWhat they receive
si-544ExperimentalThe study consists of 2 parts, an SAD and an MAD part. In both parts, subjects will be treated in cohorts and will be randomized within each cohort to treatment with si-544 or placebo.
Receives: Drug: si-544
PlaceboPlacebo comparatorThe study consists of 2 parts, an SAD and an MAD part. In both parts, subjects will be treated in cohorts and will be randomized within each cohort to treatment with si-544 or placebo.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse events (AEs)

    AEs will be summarized and tabulated according to the primary system organ class and preferred term. Separate analyses will be conducted using severity, seriousness, and relationship to the IMP.

    Measured: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  2. Adverse events (AEs)

    AEs will be summarized and tabulated according to the primary system organ class and preferred term. Separate analyses will be conducted using severity, seriousness, and relationship to the IMP.

    Measured: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  3. Change from Baseline in hematology parameter plateletes to all assessments during the study

    For the analyses of hematology parameter platelets the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  4. Change from Baseline in hematology parameter plateletes to all assessments during the study

    For the analyses of hematology parameter platelets the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  5. Change from Baseline in hematology parameter erythrocytes to all assessments during the study

    For the analyses of hematology parameter erythrocytes the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  6. Change from Baseline in hematology parameter erythrocytes to all assessments during the study

    For the analyses of hematology parameter erythrocytes the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  7. Change from Baseline in hematology parameter leukocytes to all assessments during the study

    For the analyses of hematology parameter leukocytes the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  8. Change from Baseline in hematology parameter leukocytes to all assessments during the study

    For the analyses of hematology parameter leukocytes the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  9. Change from Baseline in hematology parameter differential leukocyte count to all assessments during the study

    For the analyses of hematology parameter differential leukocyte count the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  10. Change from Baseline in hematology parameter differential leukocyte count to all assessments during the study

    For the analyses of hematology parameter differential leukocyte count the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  11. Change from Baseline in hematology parameter hemoglobin to all assessments during the study

    For the analyses of hematology parameter hemoglobin the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  12. Change from Baseline in hematology parameter hemoglobin to all assessments during the study

    For the analyses of hematology parameter hemoglobin the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  13. Change from Baseline in hematology parameter hematocrit to all assessments during the study

    For the analyses of hematology parameter hematocrit the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  14. Change from Baseline in hematology parameter hematocrit to all assessments during the study

    For the analyses of hematology parameter hematocrit the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  15. Change from Baseline in hematology parameter mean corpuscular volume to all assessments during the study

    For the analyses of hematology parameter mean corpuscular volume the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  16. Change from Baseline in hematology parameter mean corpuscular volume to all assessments during the study

    For the analyses of hematology parameter mean corpuscular volume the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  17. Change from Baseline in hematology parameter mean corpuscular hemoglobin to all assessments during the study

    For the analyses of hematology parameter mean corpuscular hemoglobin the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  18. Change from Baseline in hematology parameter mean corpuscular hemoglobin to all assessments during the study

    For the analyses of hematology parameter mean corpuscular hemoglobin the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection

    Measured: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  19. Change from Baseline in hematology parameter mean corpuscular hemoglobin concentration to all assessments during the study

    For the analyses of hematology parameter mean corpuscular hemoglobin concentration the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  20. Change from Baseline in hematology parameter mean corpuscular hemoglobin concentration to all assessments during the study

    For the analyses of hematology parameter mean corpuscular hemoglobin concentration the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  21. Change from Baseline in alanine aminotransferase to all assessments during the study

    For the analyses of alanine aminotransferase the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  22. Change from Baseline in alanine aminotransferase to all assessments during the study

    For the analyses of alanine aminotransferase the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  23. Change from Baseline in aspartate aminotransferase to all assessments during the study

    For the analyses of aspartate aminotransferase the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  24. Change from Baseline in aspartate aminotransferase to all assessments during the study

    For the analyses of aspartate aminotransferase the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  25. Change from Baseline in gamma-glutamyl transferase to all assessments during the study

    For the analyses of gamma-glutamyl transferase the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  26. Change from Baseline in gamma-glutamyl transferase to all assessments during the study

    For the analyses of gamma-glutamyl transferase the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  27. Change from Baseline in alkaline phosphatase to all assessments during the study

    For the analyses of alkaline phosphatase the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  28. Change from Baseline in alkaline phosphatase to all assessments during the study

    For the analyses of alkaline phosphatase the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  29. Change from Baseline in total bilirubin to all assessments during the study

    For the analyses of total bilirubin the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  30. Change from Baseline in total bilirubin to all assessments during the study

    For the analyses of total bilirubin the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  31. Change from Baseline in unconjugated (indirect) bilirubin to all assessments during the study

    For the analyses of unconjugated (indirect) bilirubin the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  32. Change from Baseline in unconjugated (indirect) bilirubin to all assessments during the study

    For the analyses of unconjugated (indirect) bilirubin the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  33. Change from Baseline in conjugated (direct) bilirubin to all assessments during the study

    For the analyses of conjugated (direct) bilirubin the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  34. Change from Baseline in conjugated (direct) bilirubin to all assessments during the study

    For the analyses of conjugated (direct) bilirubin the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  35. Change from Baseline in blood urea nitrogen to all assessments during the study

    For the analyses of blood urea nitrogen the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  36. Change from Baseline in blood urea nitrogen to all assessments during the study

    For the analyses of blood urea nitrogen the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  37. Change from Baseline in creatinine to all assessments during the study

    For the analyses of creatinine the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  38. Change from Baseline in creatinine to all assessments during the study

    For the analyses of creatinine the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  39. Change from Baseline in uric acid to all assessments during the study

    For the analyses of uric acid the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  40. Change from Baseline in uric acid to all assessments during the study

    For the analyses of uric acid the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  41. Change from Baseline in estimated glomerular filtration rate to all assessments during the study

    For the analyses of estimated glomerular filtration rate the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  42. Change from Baseline in estimated glomerular filtration rate to all assessments during the study

    For the analyses of estimated glomerular filtration rate the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  43. Change from Baseline in blood biochemistry parameter sodium to all assessments during the study

    For the analyses of blood biochemistry parameter sodium the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  44. Change from Baseline in blood biochemistry parameter sodium to all assessments during the study

    For the analyses of blood biochemistry parameter sodium the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  45. Change from Baseline in blood biochemistry parameter potassium to all assessments during the study

    For the analyses of blood biochemistry parameter potassium the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  46. Change from Baseline in blood biochemistry parameter potassium to all assessments during the study

    For the analyses of blood biochemistry parameter potassium the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  47. Change from Baseline in blood biochemistry parameter magnesium to all assessments during the study

    For the analyses of blood biochemistry parameter magnesium the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  48. Change from Baseline in blood biochemistry parameter magnesium to all assessments during the study

    For the analyses of blood biochemistry parameter magnesium the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  49. Change from Baseline in blood biochemistry parameter chloride to all assessments during the study

    For the analyses of blood biochemistry parameter chloride the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  50. Change from Baseline in blood biochemistry parameter chloride to all assessments during the study

    For the analyses of blood biochemistry parameter chloride the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  51. Change from Baseline in blood biochemistry parameter inorganic phosphate to all assessments during the study

    For the analyses of blood biochemistry parameter inorganic phosphate the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  52. Change from Baseline in blood biochemistry parameter inorganic phosphate to all assessments during the study

    For the analyses of blood biochemistry parameter inorganic phosphate the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  53. Change from Baseline in blood biochemistry parameter calcium to all assessments during the study

    For the analyses of blood biochemistry parameter calcium the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  54. Change from Baseline in blood biochemistry parameter calcium to all assessments during the study

    For the analyses of blood biochemistry parameter calcium the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  55. Change from Baseline in blood biochemistry parameter creatine phosphokinase to all assessments during the study

    For the analyses of blood biochemistry parameter creatine phosphokinase the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  56. Change from Baseline in blood biochemistry parameter creatine phosphokinase to all assessments during the study

    For the analyses of blood biochemistry parameter creatine phosphokinase the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  57. Change from Baseline in blood biochemistry parameter amylase to all assessments during the study

    For the analyses of blood biochemistry parameter amylase the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  58. Change from Baseline in blood biochemistry parameter amylase to all assessments during the study

    For the analyses of blood biochemistry parameter amylase the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  59. Change from Baseline in blood biochemistry parameter lipase to all assessments during the study

    For the analyses of blood biochemistry parameter lipase the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  60. Change from Baseline in blood biochemistry parameter lipase to all assessments during the study

    For the analyses of blood biochemistry parameter lipase the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  61. Change from Baseline in blood biochemistry parameter total protein to all assessments during the study

    For the analyses of blood biochemistry parameter total protein the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  62. Change from Baseline in blood biochemistry parameter total protein to all assessments during the study

    For the analyses of blood biochemistry parameter total protein the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  63. Change from Baseline in blood biochemistry parameter albumin to all assessments during the study

    For the analyses of blood biochemistry parameter albumin the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  64. Change from Baseline in blood biochemistry parameter albumin to all assessments during the study

    For the analyses of blood biochemistry parameter albumin the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  65. Change from Baseline in blood biochemistry parameter glucose (non-fasting) to all assessments during the study

    For the analyses of blood biochemistry parameter glucose (non-fasting) the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  66. Change from Baseline in blood biochemistry parameter glucose (non-fasting) to all assessments during the study

    For the analyses of blood biochemistry parameter glucose (non-fasting) the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  67. Change from Baseline in blood biochemistry hemoglobin A1c to all assessments during the study

    For the analyses of blood biochemistry parameter hemoglobin A1c the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  68. Change from Baseline in blood biochemistry hemoglobin A1c to all assessments during the study

    For the analyses of blood biochemistry parameter hemoglobin A1c the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  69. Change from Baseline in blood biochemistry triglycerides to all assessments during the study

    For the analyses of blood biochemistry parameter triglycerides the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  70. Change from Baseline in blood biochemistry triglycerides to all assessments during the study

    For the analyses of blood biochemistry parameter triglycerides the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  71. Change from Baseline in blood biochemistry cholesterol to all assessments during the study

    For the analyses of blood biochemistry parameter cholesterol the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  72. Change from Baseline in blood biochemistry cholesterol to all assessments during the study

    For the analyses of blood biochemistry parameter cholesterol the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  73. Change from Baseline in blood biochemistry ferritin to all assessments during the study

    For the analyses of blood biochemistry parameter ferritin the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  74. Change from Baseline in blood biochemistry ferritin to all assessments during the study

    For the analyses of blood biochemistry parameter ferritin the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  75. Change from Baseline in blood biochemistry D-dimer to all assessments during the study

    For the analyses of blood biochemistry parameter D-dimer the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  76. Change from Baseline in blood biochemistry D-dimer to all assessments during the study

    For the analyses of blood biochemistry parameter D-dimer the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  77. Change from Baseline in blood biochemistry lactate dehydrogenase to all assessments during the study

    For the analyses of blood biochemistry parameter lactate dehydrogenase the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  78. Change from Baseline in blood biochemistry lactate dehydrogenase to all assessments during the study

    For the analyses of blood biochemistry parameter lactate dehydrogenase the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  79. Change from Baseline in blood biochemistry C-reative protein to all assessments during the study

    For the analyses of blood biochemistry parameter C-reactive protein the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  80. Change from Baseline in blood biochemistry C-reative protein to all assessments during the study

    For the analyses of blood biochemistry parameter C-reactive protein the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  81. Change from Baseline in blood coagulation partial thromboplastin time to all assessments during the study

    For the analyses of blood coagulation parameter partial thromboplastin time the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  82. Change from Baseline in blood coagulation partial thromboplastin time to all assessments during the study

    For the analyses of blood coagulation parameter partial thromboplastin time the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  83. Change from Baseline in blood coagulation parameter prothrombin time to all assessments during the study

    For the analyses of blood coagulation parameter prothrombin time the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  84. Change from Baseline in blood coagulation parameter prothrombin time to all assessments during the study

    For the analyses of blood coagulation parameter prothrombin time the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  85. Change from Baseline in blood coagulation parameter international normalized ratio (INR) all assessments during the study

    For the analyses of blood coagulation parameter international normalized ratio (INR) the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  86. Change from Baseline in blood coagulation parameter international normalized ratio (INR) all assessments during the study

    For the analyses of blood coagulation parameter international normalized ratio (INR) the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  87. Change from Baseline in urinalysis parameter pH to all assessments during the study

    For the analyses of urinalysis parameter pH the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  88. Change from Baseline in urinalysis parameter pH to all assessments during the study

    For the analyses of urinalysis parameter pH the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  89. Change from Baseline in urinalysis parameter leukocytes to all assessments during the study

    For the analyses of urinalysis parameter leukocytes the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  90. Change from Baseline in urinalysis parameter leukocytes to all assessments during the study

    For the analyses of urinalysis parameter leukocytes the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  91. Change from Baseline in urinalysis parameter nitrites to all assessments during the study

    For the analyses of urinalysis parameter nitrites the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  92. Change from Baseline in urinalysis parameter nitrites to all assessments during the study

    For the analyses of urinalysis parameter nitrites the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  93. Change from Baseline in urinalysis parameter blood to all assessments during the study

    For the analyses of urinalysis parameter blood the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  94. Change from Baseline in urinalysis parameter blood to all assessments during the study

    For the analyses of urinalysis parameter blood the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  95. Change from Baseline in urinalysis parameter protein to all assessments during the study

    For the analyses of urinalysis parameter protein the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  96. Change from Baseline in urinalysis parameter protein to all assessments during the study

    For the analyses of urinalysis parameter protein the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  97. Change from Baseline in urinalysis parameter glucose to all assessments during the study

    For the analyses of urinalysis parameter glucose the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  98. Change from Baseline in urinalysis parameter glucose to all assessments during the study

    For the analyses of urinalysis parameter glucose the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  99. Change from Baseline in urinalysis parameter ketones to all assessments during the study

    For the analyses of urinalysis parameter ketones the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  100. Change from Baseline in urinalysis parameter ketones to all assessments during the study

    For the analyses of urinalysis parameter ketones the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  101. Change from Baseline in urinalysis parameter urobilinogen to all assessments during the study

    For the analyses of urinalysis parameter urobilinogen the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  102. Change from Baseline in urinalysis parameter urobilinogen to all assessments during the study

    For the analyses of urinalysis parameter urobilinogen the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  103. Change from Baseline in urinalysis parameter bilirubin to all assessments during the study

    For the analyses of urinalysis parameter bilirubin the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  104. Change from Baseline in urinalysis parameter bilirubin to all assessments during the study

    For the analyses of urinalysis parameter bilirubin the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  105. Change from Baseline in 12-lead ECG parameter PR-interval to all assessments during the study

    For the analyses of 12-lead ECG parameter PR-interval the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  106. Change from Baseline in 12-lead ECG parameter PR-interval to all assessments during the study

    For the analyses of 12-lead ECG parameter PR-interval the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  107. Change from Baseline in 12-lead ECG parameter QRS-interval to all assessments during the study

    For the analyses of 12-lead ECG parameter QRS-interval the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  108. Change from Baseline in 12-lead ECG parameter QRS-interval to all assessments during the study

    For the analyses of 12-lead ECG parameter QRS-interval the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  109. Change from Baseline in 12-lead ECG parameter QT-interval to all assessments during the study

    For the analyses of 12-lead ECG parameter QT-interval the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  110. Change from Baseline in 12-lead ECG parameter QT-interval to all assessments during the study

    For the analyses of 12-lead ECG parameter QT-interval the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  111. Change from Baseline in 12-lead ECG parameter QTc[F]-interval to all assessments during the study

    For the analyses of 12-lead ECG parameter QTc[F]-interval the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  112. Change from Baseline in 12-lead ECG parameter QTc[F]-interval to all assessments during the study

    For the analyses of 12-lead ECG parameter QTc[F]-interval the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  113. Change from Baseline in peripheral oxygen saturation to all assessments during the study

    For the analyses of peripheral oxygen saturation the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  114. Change from Baseline in peripheral oxygen saturation to all assessments during the study

    For the analyses of peripheral oxygen saturation the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  115. Change from Baseline in blood pressure to all assessments during the study

    For the analyses of blood pressure the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  116. Change from Baseline in blood pressure to all assessments during the study

    For the analyses of blood pressure the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  117. Change from Baseline in heart rate to all assessments during the study

    For the analyses of heart rate the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  118. Change from Baseline in heart rate to all assessments during the study

    For the analyses of heart rate the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  119. Change from Baseline in respiration rate to all assessments during the study

    For the analyses of respiration rate the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  120. Change from Baseline in respiration rate to all assessments during the study

    For the analyses of respiration rate the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  121. Change from Baseline in body temperature to all assessments during the study

    For the analyses of body temperature the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  122. Change from Baseline in body temperature to all assessments during the study

    For the analyses of body temperature the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    Measured: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

Secondary outcomes (9)

  1. SAD part: Plasma concentration of free si-544 in blood plasma at Day 1

    Blood collections up to 15 minutes before, and immediately, 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, and 8 hours after IMP injection. The sampling window will be ±1 minute for ≤1 hour, ±5 minutes for 2 hours, ±15 minutes for 4 hours, and ±30 minutes for 8 hours post injection.

    Plasma concentration of free si-544 in blood plasma will be analyzed by descriptive statistics by treatment group.

    Measured: Day 1

  2. MAD part: Plasma concentration of free si-544 in blood plasma at Days 1 and 25

    Blood collections up to 15 minutes before, and immediately, 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, and 8 hours after IMP injection. The sampling window will be ±1 minute for ≤1 hour, ±5 minutes for 2 hours, ±15 minutes for 4 hours, and ±30 minutes for 8 hours post injection.

    Plasma concentration of free si-544 in blood plasma will be analyzed by descriptive statistics by treatment group and visit.

    Measured: Day 1 and Day 25

  3. MAD part: Change from Baseline in number of T cells in peripheral blood at Day 29, and Weeks 8, 12, and 16

    Blood sampling window on Day 1: up to 15 minutes before IMP injection.

    Measured: Day 1, Day 29, Week 8, Week 12, and Week 16 (last visit)

  4. MAD part: Change from Baseline in immunophenotyping of T-cell subsets at Day 29, and Weeks 8, 12, and 16

    Blood sampling window on Day 1: up to 15 minutes before IMP injection.

    Measured: Day 1, Day 29, Week 8, Week 12, and Week 16 (last visit)

  5. MAD part: Change from Baseline in serum cytokine levels at Day 29, and Weeks 8, 12, and 16

    Blood sampling window on Day 1: up to 15 minutes before IMP injection.

    Measured: Day 1, Day 29, Week 8, Week 12, and Week 16 (last visit)

  6. MAD part: Optional: Change from Baseline of expression levels of Kv1.3 vs KCa3.1 of effector memory T cells at Day 29, and Weeks 8, 12, and 16

    Blood sampling window on Day 1: up to 15 minutes before IMP injection.

    Measured: Day 1, Day 29, Week 8, Week 12, and Week 16 (last visit)

  7. Change from Baseline in anti-drug antibodies against si-544 in serum at Day 29

    Blood sampling window on Day 1: up to 15 minutes before IMP injection.

    Measured: Day 1 and Day 29

  8. Change from Baseline in inflamed areas using the body surface area index at Days 15 and 29, and Weeks 8, 12, and 16

    The body surface index will be used to assess the inflamed skin areas as percentage of the total body surface area (BSA). Percentage of BSA affected by AD with each body part accounted for by: head and neck: 9%, upper limbs: 9% each, lower limbs: 18% each, anterior trunk: 18%, back: 18%, and genitals: 1%. The score for each affected area is added up with the total possible (ie, all areas affected) score for being 100 (ie, 100% of BSA).

    Measured: Day 1, Day 15, Day 29, Week 8, Week 12, and Week 16 (last visit)

  9. Change from Baseline in atopic dermatitis (AD) severity by SCOring AD (SCORAD) at Days 15 and 29, and Weeks 8, 12, and 16

    The AD severity assessment will be done by SCORing Atopic Dermatitis (SCORAD). SCORAD is a composite score of 3 components: (A) the BSA involved in AD, (B) the severity of 6 clinical signs, and (C) a subject-reported component assessing pruritus and sleep loss. The total score is calculated with a maximal total score of 103. A score <25 indicates mild, score 25-60 moderate, and score 61-103 severe AD.

    Measured: Day 1, Day 15, Day 29, Week 8, Week 12, and Week 16 (last visit)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2022
  2. Study start30 Aug 2022
  3. Primary completion1 Nov 2023
  4. Study completion1 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
The study consists of 2 parts, a single ascending dose (SAD) part, and a multiple ascending dose (MAD) part.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05383378
Sponsor's protocol ID
SEL-001
Other IDs
2021-003061-35
Status last verified
Nov 2023
First submitted
4 May 2022
Last updated
13 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Due to uncertainties in EU data protection legislation individual deidentified participant data are not shared. The main uncertainty is the concept of what "deidentified" means. It appears not to mean that the data set of a person is simply separated from the person's name. What additional operations have to be done appears to depend on technological capabilities to re-identify the persons associated with the data set. A common perception is that the technological capabilities for re-identification are permanently increasing. This could have the effect that public data sets that are regarded as deidentified now might become re-identifiable data sets in the future. Once this happens, the sponsor is no longer able to make the publication of the data sets un-happen. This could result in sanctioning by EU data protection authorities. The sponsor wants to avoid this.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing si-544 in people with Atopic Dermatitis, run by selectION Therapeutics GmbH at 5 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events (AEs) (time frame: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)). The study lists 122 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05383378.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.

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