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

• Sponsor: Baliopharm Pty Ltd (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04650126
• Collaborator: (none)
• Enrollment: 42
• Location: 1
• Arms: 2
• Actual Duration (Months): 8.4
• Patients Per Site Per Month: 5

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Biological: ATM001; Biological: ATM001 Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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.
• Actual Study Start Date: Jul 12, 2021
• Actual Primary Completion Date: Mar 24, 2022
• Actual Study Completion Date: Mar 24, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ATM001 Escalating dose levels of ATM001 administered as single dose in healthy subjects	Biological: ATM001; monovalent anti-TNF-receptor 1 antibody format; Other Names: Atrosimab
Placebo Comparator: ATM001 Placebo Escalating dose levels of ATM001 Placebo administered as single dose in healthy subjects	Biological: ATM001 Placebo; ATM001 Placebo

Outcome Measures

Primary Outcome Measures

1. pharmacokinetic (PK): Area under the analyte concentration-time curve from time 0 and extrapolated to infinite time (AUC 0-∞) [8 days]

2. PK: Area under the plasma concentration curve from administration until the last quantifiable sampling point (AUC 0-t) [8 days]

3. PK: Maximum Plasma Concentration [Cmax] [8 days]

4. PK: Terminal half life (t1/2) [8 days]

5. PK: Apparent terminal elimination rate constant (λz) [8 days]

6. PK: Mean residence time (MRT) [8 days]

7. PK: Clearance (CL) [8 days]

8. PK: Apparent volume of distribution (Vz) [8 days]

9. Any adverse event, serious adverse event (SAE) [4 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Q-Pharm	Herston	Brisbane	Australia	4006

Sponsors and Collaborators

• Baliopharm Pty Ltd

Investigators

• Principal Investigator: Kristi McLendon, MD, Q-Pharm Pty Limited

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Baliopharm Pty Ltd
• ClinicalTrials.gov Identifier: NCT04650126
• Other Study ID Numbers: ATM001-001
• First Posted: Dec 2, 2020
• Last Update Posted: Jul 21, 2022
• Last Verified: Jul 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jul 21, 2022