Inflammatory Gastrointestinal DiseasesPhase 1NCT06298032
A Study Investigating the Safety, Tolerability, Immunogenicity and Pharmacokinetics of Olamkicept in Healthy Persons
A Phase 1 study testing Olamkicept Part A and Olamkicept Part B in people with Inflammatory Gastrointestinal Diseases, run by Ferring Pharmaceuticals at 1 site in Germany.
Trial summary
Interleukin (IL)-6 is a cytokine produced in response to infection and tissue damage. IL-6 is believed to act as a key mediator in chronic inflammation and autoimmune diseases such as inflammatory bowel diseases. IL-6 is known to be involved in at least two distinct signalling pathways, classical and trans-signalling. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Gastrointestinal Diseases
- What is being tested?
- Olamkicept Part A and Olamkicept Part B
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteGermany
- Study dates
- 20 Feb 2024to 15 Nov 2024
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men ≥18 and ≤45 years of age at screening
- In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), vital signs measurements, and clinical laboratory evaluations, as assessed by the investigator (or designee) at screening and on Day -1
Who cannot join
- History of clinically significant medical conditions including, but not limited to, diseases of the renal, hepatic, respiratory, gastrointestinal, cardiovascular, neurological, musculoskeletal, psychiatric, immunological, haematological, oncological, endocrine, and metabolic systems and allergic diseases (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Placebo-controlled, Within-group Randomised, and Double-blind Trial Investigating Safety, Tolerability, and Pharmacokinetics of FE 999301 After Ascending Single and Multiple Doses in Healthy Subjects
Interleukin (IL)-6 is a cytokine produced in response to infection and tissue damage. IL-6 is believed to act as a key mediator in chronic inflammation and autoimmune diseases such as inflammatory bowel diseases. IL-6 is known to be involved in at least two distinct signalling pathways, classical and trans-signalling. The hypothesis is that classical signalling by IL-6 infers some beneficial effects (e.g. on gut barrier function), while excessive IL-6 trans-signalling may have detrimental effects. Olamkicept (FE 999301) has been shown in vitro to be a selective IL-6 trans-signalling inhibitor, and administered at lower doses (600 mg every 2nd week for 12 weeks) it has proven to induce clinical improvement for patients with ulcerative colitis. The aim of this trial is to investigate safety, tolerability, immunogenicity and pharmacokinetics of Olamkicept at higher doses (up to 2400 mg) to support the clinical development program. Our hypothesis is that treatment with higher doses of Olamkicept will result in greater clinical improvement for patients with inflammatory bowel diseases.
- Conditions
- Inflammatory Gastrointestinal Diseases
- Being tested
- Olamkicept Part A, Olamkicept Part B, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olamkicept Part ADrug
Also called FE 999301
Intravenous infusion. Single dose.
Part A consists of 3 different doses
- 1200 mg
- 1800 mg
- 2400 mg
Olamkicept Part BDrug
Also called FE 999301
Intravenous infusion. Multiple doses.
Part B consists of 3 different doses.
- 1200 mg
- 1800 mg
- 2400 mg
PlaceboDrug
Intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Olamkicept - Part A | Experimental | Not described Receives: Drug: Olamkicept Part A |
| Placebo - Part A | Placebo comparator | Not described Receives: Drug: Placebo |
| Olamkicept - Part B | Experimental | Not described Receives: Drug: Olamkicept Part B |
| Placebo - Part B | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatment-emergent adverse events, including type, intensity, and causality
Measured: End of trial (up to 64 days)
Change in vital signs from baseline to Day 36 after a single dose infusion
Number of participants with clinically significant abnormal findings in vital signs (systolic blood pressure, diastolic blood pressure, pulse, body temperature), from baseline up to and including Day 36 after a single dose infusion (part A of the study).
Measured: From baseline up to and including Day 36 after a single dose infusion
Change in vital signs from baseline to Day 64 after multiple dose infusions
Number of participants with clinically significant abnormal findings in vital signs (systolic blood pressure, diastolic blood pressure, pulse, body temperature), from baseline up to and including Day 64 after multiple dose infusions (part B of the study)
Measured: From baseline up to and including Day 64 after multiple dose infusions
Change in 12-lead electrocardiogram (ECG) from baseline to Day 36 after a single dose infusion
Number of participants with clinically significant abnormal findings in ECG (heart rate, PR interval, RR, QRS duration, QT interval, QTc interval, QRS axis), from baseline up to and including Day 36 after a single dose infusion (part A of the study)
Measured: From baseline up to and including Day 36 after a single dose infusion
Change in 12-lead electrocardiogram (ECG) from baseline to Day 64 after multiple dose infusions
Number of participants with clinically significant abnormal findings in ECG (heart rate, PR interval, RR, QRS duration, QT interval, QTc interval, QRS axis), from baseline up to and including Day 64 after multiple dose infusions (part B of the study)
Measured: From baseline up to and including Day 64 after multiple dose infusions
Change in haematology from baseline to Day 36 after a single dose infusion
Number of participants with clinically significant abnormal findings in haematology (haematocrit, haemoglobin, mean cellular volume (MCV), mean corpuscular haemoglobin content (MCH), mean corpuscular haemoglobin concentration (MCHC), platelet count, red blood cell count, reticulocytes, white blood cell count with differential count, neutrophils, eosinophils, basophils, lymphocytes, monocytes), from baseline up to and including Day 36 after a single dose infusion (part A of the study)
Measured: From baseline to Day 36 after a single dose infusion
Change in haematology from baseline to Day 64 after multiple dose infusions
Number of participants with clinically significant abnormal findings in haematology (haematocrit, haemoglobin, mean cellular volume (MCV), mean corpuscular haemoglobin content (MCH), mean corpuscular haemoglobin concentration (MCHC), platelet count, red blood cell count, reticulocytes, white blood cell count with differential count, neutrophils, eosinophils, basophils, lymphocytes, monocytes), from baseline up to and including Day 64 after multiple dose infusions (part B of the study)
Measured: From baseline to Day 64 after multiple dose infusions
Change in clinical chemistry from baseline to Day 36 after a single dose infusion
Number of participants with clinically significant abnormal findings in clinical chemistry (alanine aminotransferase (ALT), albumin, alkaline phosphatase, aspartate aminotransferase (AST), glucose, calcium, chloride, cholesterol, C-reactive protein, creatinine, estimated glomerular filtration rate (eGFR), gamma-glutamyltransferase, phosphate, potassium, sodium, thyroid stimulating hormone, free triiodothyronine, free thyroxine, total bilirubin, urea (blood urea nitrogen)), from baseline up to and including Day 36 after a single dose infusion (part A of the study)
Measured: From baseline to Day 36 after a single dose infusion
Change in clinical chemistry from baseline to Day 64 after multiple dose infusions
Number of participants with clinically significant abnormal findings in clinical chemistry (alanine aminotransferase (ALT), albumin, alkaline phosphatase, aspartate aminotransferase (AST), glucose, calcium, chloride, cholesterol, C-reactive protein, creatinine, estimated glomerular filtration rate (eGFR), gamma-glutamyltransferase, phosphate, potassium, sodium, thyroid stimulating hormone, free triiodothyronine, free thyroxine, total bilirubin, urea (blood urea nitrogen)), from baseline up to and including Day 64 after multiple dose infusions (part B of the study)
Measured: From baseline up to and including Day 64 after multiple dose infusions
Change in haemostasis parameters from baseline to Day 36 after a single dose infusion
Number of participants with clinically significant abnormal findings in haemostasis parameters (activated partial thromboplastin time, prothrombin time) from baseline up to and including Day 36 after a single dose infusion (part A of the study)
Measured: From baseline up to and including Day 36 after a single dose infusion
Change in haemostasis parameters from baseline to Day 64 after multiple dose infusions
Number of participants with clinically significant abnormal findings in haemostasis parameters (activated partial thromboplastin time, prothrombin time) from baseline up to and including Day 64 after multiple dose infusions (part B of the study)
Measured: From baseline up to and including Day 64 after multiple dose infusions
Change in urinalysis parameters from baseline to Day 36 after a single dose infusion
Number of participants with clinically significant abnormal findings in urinalysis parameters (protein, glucose, bilirubin, pH, nitrite, ketone, urobilinogen, blood, leukocytes, specific gravity) from baseline up to and including Day 36 after a single dose infusion (part A of the study)
Measured: From baseline to Day 36 after a single dose infusion
Change in urinalysis parameters from baseline to Day 64 after multiple dose infusions
Number of participants with clinically significant abnormal findings in urinalysis parameters (protein, glucose, bilirubin, pH, nitrite, ketone, urobilinogen, blood, leukocytes, specific gravity) from baseline up to and including Day 64 after multiple dose infusions (part B of the study)
Measured: From baseline up to and including Day 64 after multiple dose infusions
Secondary outcomes (20)
Single-dose PK of FE 999301: Area under the concentration-time curve from dosing to infinity (AUCinf)
Measured: From baseline up to and including Day 36 after a single dose infusion
Single-dose PK of FE 999301: Area under the concentration-time curve to last measurable concentration (AUClast)
Measured: From baseline up to and including Day 36 after a single dose infusion
Single-dose PK of FE 999301: Observed plasma concentration at end of infusion (AUCeoi)
Measured: From baseline up to and including Day 36 after a single dose infusion
Single-dose PK of FE 999301: Baseline adjusted maximum observed concentration; also referred to as maximum exposure (Cmax)
Measured: From baseline up to and including Day 36 after a single dose infusion
Single-dose PK of FE 999301: Time of maximum observed concentration (tmax)
Measured: From baseline up to and including Day 36 after a single dose infusion
Single-dose PK of FE 999301: Terminal half-life (t1/2)
Measured: From baseline up to and including Day 36 after a single dose infusion
Single-dose PK of FE 999301: Mean residence time (MRT)
Measured: From baseline up to and including Day 36 after a single dose infusion
Single-dose PK of FE 999301: Total clearance (CL)
Measured: From baseline up to and including Day 36 after a single dose infusion
Single-dose PK of FE 999301: Apparent volume of distribution at steady-state (Vss)
Measured: From baseline up to and including Day 36 after a single dose infusion
Multiple-dose PK of FE 999301: Area under concentration-time curve from dosing up to time τ, where τ is the dosing interval (AUCτ)
Measured: From baseline up to and including Day 64 after a multiple dose infusions
Multiple-dose PK of FE 999301: Area under the concentration-time curve to last measurable concentration (AUClast)
Measured: From baseline up to and including Day 64 after a multiple dose infusions
Multiple-dose PK of FE 999301: Observed accumulation index (Rac)
Measured: From baseline up to and including Day 64 after a multiple dose infusions
Multiple-dose PK of FE 999301: Observed plasma concentration at end of infusion (Ceio)
Measured: From baseline up to and including Day 64 after a multiple dose infusions
Multiple-dose PK of FE 999301: Baseline adjusted maximum observed concentration; also referred to as maximum exposure (Cmax)
Measured: From baseline up to and including Day 64 after a multiple dose infusions
Multiple-dose PK of FE 999301: Time of maximum observed concentration (tmax)
Measured: From baseline up to and including Day 64 after a multiple dose infusions
Multiple-dose PK of FE 999301: Terminal half-life (t½)
Measured: From baseline up to and including Day 64 after a multiple dose infusions
Multiple-dose PK of FE 999301: Mean residence time (MRT)
Measured: From baseline up to and including Day 64 after a multiple dose infusions
Multiple-dose PK of FE 999301: Total clearance (CL)
Measured: From baseline up to and including Day 64 after a multiple dose infusions
Multiple-dose PK of FE 999301: Apparent volume of distribution at steady-state (Vss)
Measured: Day 64
Presence of anti-FE 999301 antibodies on Days 1, 15, and 57 after multiple dose infusions
Measured: On Days 1, 15, and 57 after multiple dose infusions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start20 Feb 2024
- Primary completion15 Nov 2024
- Study completion15 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Gastrointestinal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Compliance, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06298032
- Sponsor's protocol ID
- 000414
- Status last verified
- Feb 2024
- First submitted
- 1 Feb 2024
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-controlled, Within-group Randomised, and Double-blind Trial Investigating Safety, Tolerability, and Pharmacokinetics of FE 999301 After Ascending Single and Multiple Doses in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06298032
- Acronym / sponsor ID
- 000414
- Conditions
- Inflammatory Gastrointestinal Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- 15 Nov 2024 (actual)
- Study completion
- 15 Nov 2024 (actual)
- First posted
- 7 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Interleukin (IL)-6 is a cytokine produced in response to infection and tissue damage. IL-6 is believed to act as a key mediator in chronic inflammation and autoimmune diseases such as inflammatory bowel diseases. IL-6 is known to be involved in at least two distinct signalling pathways, classical and trans-signalling. The hypothesis is that classical signalling by IL-6 infers some beneficial effects (e.g. on gut barrier function), while excessive IL-6 trans-signalling may have detrimental effects. Olamkicept (FE 999301) has been shown in vitro to be a selective IL-6 trans-signalling inhibitor, and administered at lower doses (600 mg every 2nd week for 12 weeks) it has proven to induce clinical improvement for patients with ulcerative colitis. The aim of this trial is to investigate safety, tolerability, immunogenicity and pharmacokinetics of Olamkicept at higher doses (up to 2400 mg) to support the clinical development program. Our hypothesis is that treatment with higher doses of Olamkicept will result in greater clinical improvement for patients with inflammatory bowel diseases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Olamkicept - Part A | Experimental | Drug: Olamkicept Part A |
| Placebo - Part A | Placebo comparator | Drug: Placebo |
| Olamkicept - Part B | Experimental | Drug: Olamkicept Part B |
| Placebo - Part B | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Men ≥18 and ≤45 years of age at screening
- In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), vital signs measurements, and clinical laboratory evaluations, as assessed by the investigator (or designee) at screening and on Day -1
Key exclusion criteria (1 listed)
- History of clinically significant medical conditions including, but not limited to, diseases of the renal, hepatic, respiratory, gastrointestinal, cardiovascular, neurological, musculoskeletal, psychiatric, immunological, haematological, oncological, endocrine, and metabolic systems and allergic diseases (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Olamkicept Part AAlso: FE 999301Intravenous infusion. Single dose. Part A consists of 3 different doses * 1200 mg * 1800 mg * 2400 mg | Drug | Olamkicept - Part A |
| Olamkicept Part BAlso: FE 999301Intravenous infusion. Multiple doses. Part B consists of 3 different doses. * 1200 mg * 1800 mg * 2400 mg | Drug | Olamkicept - Part B |
| PlaceboIntravenous infusion | Drug | Placebo - Part A, Placebo - Part B |
Primary outcome
Number of treatment-emergent adverse events, including type, intensity, and causality
Time frame: End of trial (up to 64 days)
Change in vital signs from baseline to Day 36 after a single dose infusion
Time frame: From baseline up to and including Day 36 after a single dose infusion
Number of participants with clinically significant abnormal findings in vital signs (systolic blood pressure, diastolic blood pressure, pulse, body temperature), from baseline up to and including Day 36 after a single dose infusion (part A of the study).
Change in vital signs from baseline to Day 64 after multiple dose infusions
Time frame: From baseline up to and including Day 64 after multiple dose infusions
Number of participants with clinically significant abnormal findings in vital signs (systolic blood pressure, diastolic blood pressure, pulse, body temperature), from baseline up to and including Day 64 after multiple dose infusions (part B of the study)
Change in 12-lead electrocardiogram (ECG) from baseline to Day 36 after a single dose infusion
Time frame: From baseline up to and including Day 36 after a single dose infusion
Number of participants with clinically significant abnormal findings in ECG (heart rate, PR interval, RR, QRS duration, QT interval, QTc interval, QRS axis), from baseline up to and including Day 36 after a single dose infusion (part A of the study)
Change in 12-lead electrocardiogram (ECG) from baseline to Day 64 after multiple dose infusions
Time frame: From baseline up to and including Day 64 after multiple dose infusions
Number of participants with clinically significant abnormal findings in ECG (heart rate, PR interval, RR, QRS duration, QT interval, QTc interval, QRS axis), from baseline up to and including Day 64 after multiple dose infusions (part B of the study)
Change in haematology from baseline to Day 36 after a single dose infusion
Time frame: From baseline to Day 36 after a single dose infusion
Number of participants with clinically significant abnormal findings in haematology (haematocrit, haemoglobin, mean cellular volume (MCV), mean corpuscular haemoglobin content (MCH), mean corpuscular haemoglobin concentration (MCHC), platelet count, red blood cell count, reticulocytes, white blood cell count with differential count, neutrophils, eosinophils, basophils, lymphocytes, monocytes), from baseline up to and including Day 36 after a single dose infusion (part A of the study)
Change in haematology from baseline to Day 64 after multiple dose infusions
Time frame: From baseline to Day 64 after multiple dose infusions
Number of participants with clinically significant abnormal findings in haematology (haematocrit, haemoglobin, mean cellular volume (MCV), mean corpuscular haemoglobin content (MCH), mean corpuscular haemoglobin concentration (MCHC), platelet count, red blood cell count, reticulocytes, white blood cell count with differential count, neutrophils, eosinophils, basophils, lymphocytes, monocytes), from baseline up to and including Day 64 after multiple dose infusions (part B of the study)
Change in clinical chemistry from baseline to Day 36 after a single dose infusion
Time frame: From baseline to Day 36 after a single dose infusion
Number of participants with clinically significant abnormal findings in clinical chemistry (alanine aminotransferase (ALT), albumin, alkaline phosphatase, aspartate aminotransferase (AST), glucose, calcium, chloride, cholesterol, C-reactive protein, creatinine, estimated glomerular filtration rate (eGFR), gamma-glutamyltransferase, phosphate, potassium, sodium, thyroid stimulating hormone, free triiodothyronine, free thyroxine, total bilirubin, urea (blood urea nitrogen)), from baseline up to and including Day 36 after a single dose infusion (part A of the study)
Change in clinical chemistry from baseline to Day 64 after multiple dose infusions
Time frame: From baseline up to and including Day 64 after multiple dose infusions
Number of participants with clinically significant abnormal findings in clinical chemistry (alanine aminotransferase (ALT), albumin, alkaline phosphatase, aspartate aminotransferase (AST), glucose, calcium, chloride, cholesterol, C-reactive protein, creatinine, estimated glomerular filtration rate (eGFR), gamma-glutamyltransferase, phosphate, potassium, sodium, thyroid stimulating hormone, free triiodothyronine, free thyroxine, total bilirubin, urea (blood urea nitrogen)), from baseline up to and including Day 64 after multiple dose infusions (part B of the study)
Change in haemostasis parameters from baseline to Day 36 after a single dose infusion
Time frame: From baseline up to and including Day 36 after a single dose infusion
Number of participants with clinically significant abnormal findings in haemostasis parameters (activated partial thromboplastin time, prothrombin time) from baseline up to and including Day 36 after a single dose infusion (part A of the study)
Change in haemostasis parameters from baseline to Day 64 after multiple dose infusions
Time frame: From baseline up to and including Day 64 after multiple dose infusions
Number of participants with clinically significant abnormal findings in haemostasis parameters (activated partial thromboplastin time, prothrombin time) from baseline up to and including Day 64 after multiple dose infusions (part B of the study)
Change in urinalysis parameters from baseline to Day 36 after a single dose infusion
Time frame: From baseline to Day 36 after a single dose infusion
Number of participants with clinically significant abnormal findings in urinalysis parameters (protein, glucose, bilirubin, pH, nitrite, ketone, urobilinogen, blood, leukocytes, specific gravity) from baseline up to and including Day 36 after a single dose infusion (part A of the study)
Change in urinalysis parameters from baseline to Day 64 after multiple dose infusions
Time frame: From baseline up to and including Day 64 after multiple dose infusions
Number of participants with clinically significant abnormal findings in urinalysis parameters (protein, glucose, bilirubin, pH, nitrite, ketone, urobilinogen, blood, leukocytes, specific gravity) from baseline up to and including Day 64 after multiple dose infusions (part B of the study)
20 secondary outcomes
Single-dose PK of FE 999301: Area under the concentration-time curve from dosing to infinity (AUCinf)
Time frame: From baseline up to and including Day 36 after a single dose infusion
Single-dose PK of FE 999301: Area under the concentration-time curve to last measurable concentration (AUClast)
Time frame: From baseline up to and including Day 36 after a single dose infusion
Single-dose PK of FE 999301: Observed plasma concentration at end of infusion (AUCeoi)
Time frame: From baseline up to and including Day 36 after a single dose infusion
Single-dose PK of FE 999301: Baseline adjusted maximum observed concentration; also referred to as maximum exposure (Cmax)
Time frame: From baseline up to and including Day 36 after a single dose infusion
Single-dose PK of FE 999301: Time of maximum observed concentration (tmax)
Time frame: From baseline up to and including Day 36 after a single dose infusion
Single-dose PK of FE 999301: Terminal half-life (t1/2)
Time frame: From baseline up to and including Day 36 after a single dose infusion
Single-dose PK of FE 999301: Mean residence time (MRT)
Time frame: From baseline up to and including Day 36 after a single dose infusion
Single-dose PK of FE 999301: Total clearance (CL)
Time frame: From baseline up to and including Day 36 after a single dose infusion
Single-dose PK of FE 999301: Apparent volume of distribution at steady-state (Vss)
Time frame: From baseline up to and including Day 36 after a single dose infusion
Multiple-dose PK of FE 999301: Area under concentration-time curve from dosing up to time τ, where τ is the dosing interval (AUCτ)
Time frame: From baseline up to and including Day 64 after a multiple dose infusions
Multiple-dose PK of FE 999301: Area under the concentration-time curve to last measurable concentration (AUClast)
Time frame: From baseline up to and including Day 64 after a multiple dose infusions
Multiple-dose PK of FE 999301: Observed accumulation index (Rac)
Time frame: From baseline up to and including Day 64 after a multiple dose infusions
Multiple-dose PK of FE 999301: Observed plasma concentration at end of infusion (Ceio)
Time frame: From baseline up to and including Day 64 after a multiple dose infusions
Multiple-dose PK of FE 999301: Baseline adjusted maximum observed concentration; also referred to as maximum exposure (Cmax)
Time frame: From baseline up to and including Day 64 after a multiple dose infusions
Multiple-dose PK of FE 999301: Time of maximum observed concentration (tmax)
Time frame: From baseline up to and including Day 64 after a multiple dose infusions
Multiple-dose PK of FE 999301: Terminal half-life (t½)
Time frame: From baseline up to and including Day 64 after a multiple dose infusions
Multiple-dose PK of FE 999301: Mean residence time (MRT)
Time frame: From baseline up to and including Day 64 after a multiple dose infusions
Multiple-dose PK of FE 999301: Total clearance (CL)
Time frame: From baseline up to and including Day 64 after a multiple dose infusions
Multiple-dose PK of FE 999301: Apparent volume of distribution at steady-state (Vss)
Time frame: Day 64
Presence of anti-FE 999301 antibodies on Days 1, 15, and 57 after multiple dose infusions
Time frame: On Days 1, 15, and 57 after multiple dose infusions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Compliance study director
Ferring Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Olamkicept Part A and Olamkicept Part B in people with Inflammatory Gastrointestinal Diseases, run by Ferring Pharmaceuticals at 1 site 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 2 inclusion and 1 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 19 Nov 2024. 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 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?
Number of treatment-emergent adverse events, including type, intensity, and causality (time frame: End of trial (up to 64 days)). The study lists 13 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 19 Nov 2024.