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

NCT04650126 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2022-07-21

No results posted yet for this study

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

Conditions

  • Healthy Volunteers

Interventions

BIOLOGICAL

ATM001

monovalent anti-TNF-receptor 1 antibody format

BIOLOGICAL

ATM001 Placebo

ATM001 Placebo

Sponsors & Collaborators

  • Baliopharm Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Kristi McLendon, MD · Q-Pharm Pty Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-12
Primary Completion
2022-03-24
Completion
2022-03-24

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04650126 on ClinicalTrials.gov