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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-001832-22 | EudraCT Number |
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| Name | Class |
|---|---|
| Servier | INDUSTRY |
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This study is a first-in-human phase I randomised, double-blind, placebo-controlled, evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single (IV and SC) and Multiple (IV only) Ascending Doses of OSE-127 in Healthy Subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OSE-127: Part 1 (SAD), Cohort A & Cohort B | Experimental |
| |
| Placebo: Part 1 (SAD), Cohort A & Cohort B | Placebo Comparator |
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| OSE-127: Part 2 (MAD) | Experimental |
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| Placebo: Part 2 (MAD) | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OSE-127 | Drug | mAb antagonist to CD127 receptor (or IL-7Rα) Group 1-7 6 escalating dose level groups IV SC |
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| Measure | Description | Time Frame |
|---|---|---|
| Part 1 (SAD) & Part 2 (MAD) : Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 12 weeks (for Part 1); 19 weeks (for Part 2) | |
| Part 1 (SAD) & Part 2 (MAD) : Number of Participants With Clinically Significant Findings in Physical Examinations Reported as Adverse Event | 12 weeks (for Part 1); 19 weeks (for Part 2) | |
| Part 1 (SAD) & Part 2 (MAD) : Number of Participants With Clinically Significant Change in Clinical Laboratory Results Reported as Adverse Event | 12 weeks (for Part 1); 19 weeks (for Part 2) | |
| Part 1 (SAD) & Part 2 (MAD) :Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Reported as Adverse Event | 12 weeks (for Part 1); 19 weeks (for Part 2) | |
| Part 1 (SAD) & Part 2 (MAD) :Number of Participants With Clinically Significant Change in vital signs Reported as Adverse Event | 12 weeks (for Part 1); 19 weeks (for Part 2) | |
| Part 1 (SAD) & Part 2 (MAD) :Number of Participants With Clinically Significant Findings in Telemetry Reported as Adverse Event | 12 weeks (for Part 1); 19 weeks (for Part 2) | |
| Part 1 (SAD) & Part 2 (MAD) : Incidence of anti-drug antibody (ADA) formation | 12 weeks (for Part 1); 19 weeks (for Part 2) |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1 (SAD) & Part 2 (MAD) : Maximum Plasma Concentration [Cmax] | 12 weeks (for Part 1); 19 weeks (for Part 2) | |
| Part 1 (SAD) & Part 2 (MAD) : Average serum Concentration over the dosing interval [Cavg] | 12 weeks (for Part 1); 19 weeks (for Part 2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frédérique Corallo, MD | OSE Immunotherapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SGS Life Sciences (SGS LS), Clinical Pharmacology Unit (CPU) | Antwerp | 2060 | Belgium |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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Part 1 (SAD) primary objective : safety and tolerability profile of single ascending IV (Cohort A) and SC (Cohort B) doses given to healthy subjects, compared to placebo.
Part 2 (MAD) primary objective : safety and tolerability profile of two IV doses given on two separate occasions to healthy subjects, compared to placebo.
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| Placebo | Drug | Vehicle study drug |
|
| OSE-127 | Drug | mAb antagonist to CD127 receptor (or IL-7Rα) Group 8-9 2 escalating dose level groups IV |
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| Part 1 (SAD) & Part 2 (MAD) : Trough serum Concentration observed at the end of the dosing interval [Ctrough] | 12 weeks (for Part 1); 19 weeks (for Part 2) |
| Part 1 (SAD) & Part 2 (MAD) : Elimination half-life associated with the terminal rate constant (λz) [T1/2] | 12 weeks (for Part 1); 19 weeks (for Part 2) |
| Part 1 (SAD) & Part 2 (MAD) : Time corresponding to the Cmax [Tmax] | 12 weeks (for Part 1); 19 weeks (for Part 2) |
| Part 1 (SAD) & Part 2 (MAD) : Area Under the serum concentration-time Curve from time zero till X days postdose [AUCτ] | 12 weeks (for Part 1); 19 weeks (for Part 2) |
| Part 1 (SAD) & Part 2 (MAD) : AUC calculated between time of administration and last quantifiable concentration [AUClast] | 12 weeks (for Part 1); 19 weeks (for Part 2) |
| Part 1 (SAD) & Part 2 (MAD) : AUC extrapolated to infinity [AUCinf] | 12 weeks (for Part 1); 19 weeks (for Part 2) |
| Part 1 (SAD) & Part 2 (MAD) : AUC over the dosing interval [AUC0-τ]. | 12 weeks (for Part 1); 19 weeks (for Part 2) |
| Part 1 (SAD) & Part 2 (MAD) : Accumulation Ratio [Rac]. | 12 weeks (for Part 1); 19 weeks (for Part 2) |
| Part 1 (SAD) & Part 2 (MAD) : CD-127 Receptor Occupancy [RO] | 12 weeks (for Part 1); 19 weeks (for Part 2) |
| Part 1 (SAD) & Part 2 (MAD) : Effect on total lymphocyte count | 12 weeks (for Part 1); 19 weeks (for Part 2) |
| D003092 | Colitis |
| D003108 | Colonic Diseases |