Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Atrosimab (ATM001) in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Biological: ATM001; Biological: ATM001 Placebo

• 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

Study Timeline

• Study First Submitted: 2020-11-05
• Study First Submitted QC: 2020-11-25
• Study First Posted: 2020-12-02
• Status Verified: 2021-07
• Study Start: 2021-07-12
• Primary Completion: 2022-03-24
• Study Completion: 2022-03-24
• Last Update Submitted: 2022-07-20
• Last Update Posted: 2022-07-21

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

Arm && Interventions

Group	Intervention	Description
ATM001	ATM001	Escalating dose levels of ATM001 administered as single dose in healthy subjects
ATM001 Placebo	ATM001 Placebo	Escalating dose levels of ATM001 Placebo administered as single dose in healthy subjects

Primary Outcome Measures

Name	Time	Method
PK: Mean residence time (MRT)	8 days
Any adverse event, serious adverse event (SAE)	4 weeks
PK: Maximum Plasma Concentration [Cmax]	8 days
PK: Clearance (CL)	8 days
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
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

Trial Locations

Locations (1)

Q-Pharm; 🇦🇺 Herston, Brisbane, Australia