Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Atrosimab (ATM001) in Healthy Volunteers
Phase 1
Completed
- Conditions
- Healthy Volunteers
- Registration Number
- NCT04650126
- Lead Sponsor
- Baliopharm Pty Ltd
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 42
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Any adverse event, serious adverse event (SAE) 4 weeks PK: Area under the plasma concentration curve from administration until the last quantifiable sampling point (AUC 0-t) 8 days PK: Apparent terminal elimination rate constant (λz) 8 days PK: Apparent volume of distribution (Vz) 8 days PK: Maximum Plasma Concentration [Cmax] 8 days PK: Clearance (CL) 8 days pharmacokinetic (PK): Area under the analyte concentration-time curve from time 0 and extrapolated to infinite time (AUC 0-∞) 8 days PK: Terminal half life (t1/2) 8 days PK: Mean residence time (MRT) 8 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Q-Pharm
🇦🇺Herston, Brisbane, Australia
Q-Pharm🇦🇺Herston, Brisbane, Australia