A Phase I, Randomized, Double-blind, Parallel Group and Placebo-controlled Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Atrosimab in Response to Single Ascending Intravenous Infusion Doses.
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Healthy Volunteers
- Sponsor
- Baliopharm Pty Ltd
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Any adverse event, serious adverse event (SAE)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
This is a double-blind, parallel group and placebo-controlled clinical study to assess safety tolerability, pharmacokinetics and pharmacodynamics of Atrosimab in healthy volunteers
Investigators
Eligibility Criteria
Inclusion Criteria
- •healthy male subjects
- •body mass index 18-32 kg/m2
- •normal physical examination, clinical laboratory values and ECG
- •additional inclusion criteria apply
Exclusion Criteria
- •febrile or infectious illness at least 7 days prior to the first administration
- •any active physical disease, acute or chronic
- •history of alcohol or drug abuse
- •history of chronic or recurrent metabolic, renal, hepatic, pulmonary, gastrointestinal, neurological, endocrinological, immunological, psychiatric, or cardio-vascular disease, myopathies and bleeding tendency
- •additional exclusion criteria apply
Outcomes
Primary Outcomes
Any adverse event, serious adverse event (SAE)
Time Frame: 4 weeks
PK: Area under the plasma concentration curve from administration until the last quantifiable sampling point (AUC 0-t)
Time Frame: 8 days
PK: Apparent terminal elimination rate constant (λz)
Time Frame: 8 days
PK: Apparent volume of distribution (Vz)
Time Frame: 8 days
PK: Maximum Plasma Concentration [Cmax]
Time Frame: 8 days
PK: Clearance (CL)
Time Frame: 8 days
pharmacokinetic (PK): Area under the analyte concentration-time curve from time 0 and extrapolated to infinite time (AUC 0-∞)
Time Frame: 8 days
PK: Terminal half life (t1/2)
Time Frame: 8 days
PK: Mean residence time (MRT)
Time Frame: 8 days