NCT03980080
Completed
Phase 1
Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study for the Assessment of Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single and Multiple Ascending Intravenous and Subcutaneous Doses of OSE-127 in Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- OSE-127
- Conditions
- Healthy Subjects
- Sponsor
- OSE Immunotherapeutics
- Enrollment
- 63
- Locations
- 1
- Primary Endpoint
- Part 1 (SAD) & Part 2 (MAD) : Number of Participants With Treatment Emergent Adverse Events (TEAEs)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female, aged 18 to 65 years (extremes included). Maximum two subjects aged between 60 and 65 (extremes included) are allowed per dose group.
- •Healthy volunteers (medically stable), as determined on the basis of medical history, vital signs, clinical laboratory testing, and general physical examination performed at screening and deemed appropriate by the Investigator.
- •Electrocardiogram (ECG) within normal range, or showing no clinically relevant deviations, as judged by the Investigator.
- •Weighs at least 50 kg and no more than 100 kg and has a Body Mass Index (BMI) within normal range: 19.0 ≤ BMI ≤ 30.0 kg/m².
- •Negative urine test for selected drugs of abuse at screening.
- •Negative alcohol breath test at screening.
- •Female subjects is postmenopausal, surgically sterile (having had a hysterectomy or bilateral oophorectomy) and/or is using a highly effective method of contraception (from 2 weeks before first study drug administration until 28 days after the last follow-up visit, when it is confirmed that the RO of the subject \<20% or 5 t1/2 whichever is longer).
- •Female subject has a negative pregnancy test at screening.
- •Non-vasectomized male subjects having a female partner of childbearing potential must agree to the use of a highly effective method of contraception (from the first study drug administration until 28 days after the last follow-up visit, when it is confirmed that the RO of the subject \<20% or 5 t1/2 whichever is longer).
- •Willing to adhere to the prohibitions and restrictions specified in the protocol.
Exclusion Criteria
- •A history of any clinically significant (as determined by the Investigator) cardiac, endocrinology, hematology, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy excluding non-melanoma skin cancer.
- •A known allergy, hypersensitivity, or intolerance to any of the excipients in the formulation of the study drug.
- •The subject has a history of severe allergic or anaphylactic reactions.
- •The suject has a history of consuming more than 14 units of alcoholic beverages per week for male subjects, and more than 10 units for females. Or a history of alcoholism, or drug/chemical/substance abuse within the past 2 years prior to screening.
- •Evidence or history of any clinically significant infections within the past 3 months.
- •Subject with known clinically relevant immunological disorders, or auto-immune disorders (e.g. rheumatoid arthritis, lupus erythematosus, scleroderma, etc...).
- •A positive hepatitis panel (including hepatitis B surface antigen \[HBsAg\] and anti-hepatitis C virus \[HCV\] antibodies \[Abs\]) or positive human immunodeficiency virus (HIV) antibody screens.
- •The subject has a supine systolic blood pressure (SBP) \<90 or \>149 mmHg and/or a diastolic blood pressure (DBP) \<45 or \>90 mmHg, and/or a pulse rate higher than 100 beats per minute (bpm) at screening (blood pressure measurements taken after subject has been resting in a supine position for a minimum of 5 minutes).
- •Pregnant or breastfeeding women.
- •The subject has received a live vaccine (excluding flu vaccination), within 30 days prior to study drug administration, or plan to receive this type of vaccine during the study.
Arms & Interventions
OSE-127: Part 1 (SAD), Cohort A & Cohort B
Intervention: OSE-127
Placebo: Part 1 (SAD), Cohort A & Cohort B
Intervention: Placebo
OSE-127: Part 2 (MAD)
Intervention: OSE-127
Placebo: Part 2 (MAD)
Intervention: Placebo
Outcomes
Primary Outcomes
Part 1 (SAD) & Part 2 (MAD) : Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 12 weeks (for Part 1); 19 weeks (for Part 2)
Part 1 (SAD) & Part 2 (MAD) : Incidence of anti-drug antibody (ADA) formation
Time Frame: 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
Time Frame: 12 weeks (for Part 1); 19 weeks (for Part 2)
Secondary Outcomes
- 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) : AUC extrapolated to infinity [AUCinf](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))
- 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) : Effect on total lymphocyte count(12 weeks (for Part 1); 19 weeks (for Part 2))
- 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) : 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) : Accumulation Ratio [Rac].(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) : CD-127 Receptor Occupancy [RO](12 weeks (for Part 1); 19 weeks (for Part 2))
Study Sites (1)
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