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OpenTrials
Completed

NCT Number: NCT04650126

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

This is a double-blind, parallel group and placebo-controlled clinical study to assess safety tolerability, pharmacokinetics and pharmacodynamics of Atrosimab in healthy volunteers

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Q-Pharm

Herston, Brisbane, 4006, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ATM001

Biological

monovalent anti-TNF-receptor 1 antibody format

Other names: Atrosimab

ATM001 Placebo

Biological

ATM001 Placebo

Primary outcomes

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

    Time frame: 8 days

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

    Time frame: 8 days

  3. PK: Maximum Plasma Concentration [Cmax]

    Time frame: 8 days

  4. PK: Terminal half life (t1/2)

    Time frame: 8 days

  5. PK: Apparent terminal elimination rate constant (λz)

    Time frame: 8 days

  6. PK: Mean residence time (MRT)

    Time frame: 8 days

  7. PK: Clearance (CL)

    Time frame: 8 days

  8. PK: Apparent volume of distribution (Vz)

    Time frame: 8 days

  9. Any adverse event, serious adverse event (SAE)

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Baliopharm Pty Ltd

Industry

Registry information

Official study 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.

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 2, 2020
Registry last updated
Jul 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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