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HealthyPhase 1NCT07275775

Single and Multiple Dose and Food Effect Study to Evaluate the Safety, Tolerability and Pharmacokinetics of D-2570 Tablets in Healthy Subjects

A Phase 1 study testing D-2570 in people with Healthy, run by InventisBio Co., Ltd at 1 site in China.

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 randomized, double-blind, placebo-controlled single and multiple ascending dose and food effect study on PK. Subjects in the SAD and MAD study take the drug under fasting conditions, while those in the food effect (FE) study are required to take the drug under fasting or fed conditions according to the… Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
D-2570
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
1 siteChina
Study dates
13 Aug 2024to 23 Jun 2025
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 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Subjects who voluntarily take part in the study after being fully informed, sign a written informed consent form (ICF), and agree to follow procedures specified in the study protocol;
  • Subjects who can take effective contraceptive measures from the start of screening to 6 months after the last dose of the IMP;
  • Male and female subjects aged 18 to 45 years (inclusive);
  • Male weight ≥ 50 kg, female weight ≥ 45 kg. Body mass index (BMI) = body weight (kg) / height2 (m2). BMI ranging from 19 to 26 kg/m2 (inclusive);
  • Subjects without medical history of clinically significant respiratory, circulatory, digestive, urinary, hematological, endocrine, nervous system diseases, metabolic abnormalities or infections, etc.

Who cannot join

  • More than 5 cigarettes per day on average within 3 months before screening;
  • Subjects with a clinically significant history of drug allergy or specific allergic diseases (asthma, urticaria) or known allergy to the IMP or its excipients;
  • History of alcohol abuse (consuming an average of 14 units of alcohol per week within 3 months prior to screening: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine);
  • Subjects with a history of substance or drug abuse or a positive urine drug screening;
  • Blood donation or massive blood loss (>450 mL) within 3 months before screening.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Shuguang Hospital

    Shanghai, Shanghai Municipality, 200021

Other trials in China

About this study

Official title: A Phase I, Randomized, Double-Blinded, Placebo-Controlled, Single and Multiple Ascending Dose and Food Effect Study to Evaluate the Safety, Tolerability and Pharmacokinetics of D-2570 Tablets in Healthy Subjects

This is a randomized, double-blind, placebo-controlled single and multiple ascending dose and food effect study on PK. Subjects in the SAD and MAD study take the drug under fasting conditions, while those in the food effect (FE) study are required to take the drug under fasting or fed conditions according to the protocol.

Conditions
Healthy
Being tested
D-2570, Placebo

What participants receive

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

  • D-2570Drug

    D-2570 is a novel inhibitor targeting the TYK2 pseudokinase domain, which can inhibit the release of inflammatory factors and participate in immune regulation. D-2570 is being developed as a potential oral therapeutic drug for patients with psoriasis, ulcerative colitis, SLE, and other conditions.

  • PlaceboDrug

    A placebo refers to a tablet that has no therapeutic effect on medication.

Study groups in NCT07275775
Study groupRoleWhat they receive
Compare the safety and tolerability of D-2570 tablets with Placebo for evaluationExperimentalTo assess the safety and tolerability of single, multiple doses and food effect trial of D-2570 tablets and Placebo in healthy subjects.
Receives: Drug: D-2570; Drug: Placebo
Characterize the pharmacokinetics of single, multiple doses of D-2570 tablets and PlaceboExperimentalTo characterize the pharmacokinetics (PK) of single, multiple doses of D-2570 tablets and Placebo in healthy subjects.
Receives: Drug: D-2570; Drug: Placebo
Compare the effects of D-2570 with Placebo on the QT/QTc interval for assessExperimentalTo assess the effects of D-2570 and Placebo on the QT/QTc interval in healthy subjects.
Receives: Drug: D-2570; Drug: Placebo
Compare the effects of multiple doses D-2570 with Placebo on serum IL-17AExperimentalTo assess the effects of multiple doses D-2570 and Placebo on serum IL-17A in healthy subjects.
Receives: Drug: D-2570; Drug: Placebo
Assess the effects of regular and high-fat on the pharmacokinetics of D-2570 tabletsExperimentalTo assess the effects of regular and high-fat on the pharmacokinetics of D-2570 tablets.
Receives: Drug: D-2570
Evaluate the relative bioavailability among health benefits of D-2570 tablets (9 mg specification)ExperimentalTo evaluate the relative bioavailability among health benefits of D-2570 tablets (9 mg specification) and D-2570 tablets (3 mg specification)
Receives: Drug: D-2570

What is being measured

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

  1. Incidence of adverse events

    Incidence of adverse events

    Measured: During the procedure

  2. Result of vital signs

    Test of resting blood pressure.

    Measured: During the procedure

  3. Result of vital signs

    Test of resting heart pulse.

    Measured: During the procedure

  4. Result of vital signs

    Test of respiratory rate.

    Measured: During the procedure

  5. Result of vital signs

    Test of body temperature.

    Measured: During the procedure

  6. Result of physical examination

    Test of height (meters)

    Measured: During the procedure

  7. Result of physical examination

    Test of weight (kilograms)

    Measured: During the procedure

  8. Result of electrocardiogram

    Test of beats per minute

    Measured: During the procedure

  9. Result of electrocardiogram

    Test of RR Interva

    Measured: During the procedure

  10. Result of electrocardiogram

    Test of PR Interva

    Measured: During the procedure

  11. Result of electrocardiogram

    Test of QRS Interva

    Measured: During the procedure

  12. Result of electrocardiogram

    Test of QT Interva

    Measured: During the procedure

  13. Result of electrocardiogram

    Test of QTcF msec

    Measured: During the procedure

  14. Result of PK endpoints

    Tmax

    Measured: Day1 to Day7 of group SAD

  15. Result of PK endpoints

    Tmax

    Measured: Day1 to Day13 of group MAD

  16. Result of PK endpoints

    Tmax

    Measured: Day1 to Day7 for every cycle of group FE

  17. Result of PK endpoints

    Cmax

    Measured: Day1 to Day7 of group SAD

  18. Result of PK endpoints

    Cmax

    Measured: Day1 to Day13 of group MAD

  19. Result of PK endpoints

    Cmax

    Measured: Day1 to Day7 for every cycle of group FE

  20. Result of PK endpoints

    t1/2

    Measured: Day1 to Day7 of group SAD

  21. Result of PK endpoints

    t1/2

    Measured: Day1 to Day13 of group MAD

  22. Result of PK endpoints

    t1/2

    Measured: Day1 to Day7 for every cycle of group FE

  23. Result of PK endpoints

    MRT

    Measured: Day1 to Day7 of group SAD

  24. Result of PK endpoints

    MRT

    Measured: Day1 to Day13 of group MAD

  25. Result of PK endpoints

    MRT

    Measured: Day1 to Day7 for every cycle of group FE

  26. Result of PK endpoints

    AUC0-∞

    Measured: Day1 to Day7 of group SAD

  27. Result of PK endpoints

    AUC0-∞

    Measured: Day1 to Day13 of group MAD

  28. Result of PK endpoints

    AUC0-∞

    Measured: Day1 to Day7 for every cycle of group FE

  29. Result of PK endpoints

    AUC0-t

    Measured: Day1 to Day7 of group SAD

  30. Result of PK endpoints

    AUC0-t

    Measured: Day1 to Day13 of group MAD

  31. Result of PK endpoints

    AUC0-t

    Measured: Day1 to Day7 for every cycle of group FE

  32. Result of PK endpoints

    CL/F

    Measured: Day1 to Day7 of group SAD

  33. Result of PK endpoints

    CL/F

    Measured: Day1 to Day13 of group MAD

  34. Result of PK endpoints

    CL/F

    Measured: Day1 to Day7 for every cycle of group FE

  35. Result of PK endpoints

    Vz/F

    Measured: Day1 to Day7 of group SAD

  36. Result of PK endpoints

    Vz/F

    Measured: Day1 to Day13 of group MAD

  37. Result of PK endpoints

    Vz/F

    Measured: Day1 to Day7 for every cycle of group FE

  38. Assessment of hematology test

    Red blood cell count

    Measured: During the procedure

  39. Assessment of hematology test

    Hemoglobin measurement

    Measured: During the procedure

  40. Assessment of hematology test

    Hematocrit measurement

    Measured: During the procedure

  41. Assessment of hematology test

    Platelet count

    Measured: During the procedure

  42. Assessment of hematology test

    White blood cell count

    Measured: During the procedure

  43. Assessment of hematology test

    Lymphocyte count

    Measured: During the procedure

  44. Assessment of hematology test

    Neutrophil count

    Measured: During the procedure

  45. Assessment of hematology test

    Monocyte count

    Measured: During the procedure

  46. Assessment of hematology test

    Eosinophil count

    Measured: During the procedure

  47. Assessment of hematology test

    Basophil count

    Measured: During the procedure

  48. Assessment of urinalysis test

    pH measurement

    Measured: During the procedure

  49. Assessment of urinalysis test

    Protein detection

    Measured: During the procedure

  50. Assessment of urinalysis test

    White blood cells count

    Measured: During the procedure

  51. Assessment of urinalysis test

    Red blood cells count

    Measured: During the procedure

  52. Assessment of urinalysis test

    Glucose measurement

    Measured: During the procedure

  53. Assessment of urinalysis test

    Specific gravity measurement

    Measured: During the procedure

  54. Assessment of coagulation parameters test

    Thrombin time

    Measured: During the procedure

  55. Assessment of coagulation parameters test

    Partial thromboplastin time

    Measured: During the procedure

  56. Assessment of coagulation parameters test

    International normalized ratio

    Measured: During the procedure

  57. Assessment of coagulation parameters test

    Fibrinogen

    Measured: During the procedure

  58. Assessment of blood biochemistry test

    Sodium

    Measured: During the procedure

  59. Assessment of blood biochemistry test

    Potassium

    Measured: During the procedure

  60. Assessment of blood biochemistry test

    Calcium

    Measured: During the procedure

  61. Assessment of blood biochemistry test

    Chlorine

    Measured: During the procedure

  62. Assessment of blood biochemistry test

    Total protein

    Measured: During the procedure

  63. Assessment of blood biochemistry test

    Albumin

    Measured: During the procedure

  64. Assessment of blood biochemistry test

    Alkaline phosphatase

    Measured: During the procedure

  65. Assessment of blood biochemistry test

    Alanine aminotransferase

    Measured: During the procedure

  66. Assessment of blood biochemistry test

    Aspartate aminotransferase

    Measured: During the procedure

  67. Assessment of blood biochemistry test

    Direct bilirubin

    Measured: During the procedure

  68. Assessment of blood biochemistry test

    Indirect bilirubin

    Measured: During the procedure

  69. Assessment of blood biochemistry test

    Total bilirubin

    Measured: During the procedure

  70. Assessment of blood biochemistry test

    Gamma glutamyl transferase

    Measured: During the procedure

  71. Assessment of blood biochemistry test

    Uric acid

    Measured: During the procedure

  72. Assessment of blood biochemistry test

    Creatinine

    Measured: During the procedure

  73. Assessment of blood biochemistry test

    Creatine kinase

    Measured: During the procedure

  74. Assessment of blood biochemistry test

    Urea

    Measured: During the procedure

  75. Assessment of blood biochemistry test

    Glucose

    Measured: During the procedure

  76. Assessment of blood biochemistry test

    Total cholesterol

    Measured: During the procedure

  77. Assessment of blood biochemistry test

    Triglycerides

    Measured: During the procedure

Secondary outcomes (4)
  1. Result of safety endpoint

    Test of QT Interva.

    Measured: During the procedure

  2. Result of safety endpoint

    Test of QTc Interva.

    Measured: During the procedure

  3. Result of PD endpoint

    Test of serum IL-17A.

    Measured: Day1 of group SAD

  4. Result of PD endpoint

    Test of serum IL-17A.

    Measured: Day1 and Day7 of group MAD

Timeline

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

  1. First posted10 Dec 2025
  2. Study start13 Aug 2024
  3. Primary completion23 Jun 2025
  4. Study completion23 Jun 2025

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
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07275775
Sponsor's protocol ID
D2570-102
Status last verified
Jun 2025
First submitted
4 Nov 2024
Last updated
10 Dec 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing D-2570 in people with Healthy, run by InventisBio Co., Ltd at 1 site in China.

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 5 inclusion and 5 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 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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. 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?

Incidence of adverse events (time frame: During the procedure). The study lists 77 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 10 Dec 2025.

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