Clinical Trial

A Safety and Pharmacokinetics Study of Complarate (Tocilizumab Biosimilar Solution) and Actemra® in Healthy Volunteers

Active, Not Recruiting Phase 1
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Summary
This is a randomized single-blind comparative parallel group study of the safety, pharmacokinetics of the solution form of Complarate and Actemra® in healthy volunteers. Participants received a single subcutaneous dose of tocilizumab 162 mg. The follow up period was 43 days.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-06-28.
Status change: Recruiting → Active, Not Recruiting 2025-07-28
Trial Details
NCT Number NCT06488521
Lead Sponsor AO GENERIUM
Conditions Healthy Volunteers
Enrollment 256 participants
Start Date 2024-06-20
Primary Completion 2025-04-30 (estimated)
Study Completion 2025-09-30 (estimated)
Updated on ClinicalTrials.gov 2025-07-30