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

StatusCompleted
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Trial completed Show 4 more changesShow less
    • Study completion date changed from estimate of Sep 30, 2025 to Jul 28, 2025
    • Eligibility criteria expanded, about 26 words
    • Secondary endpoints: details revised at 1 of 2 entries
    • Site details revised at 2 of 3 sites
  2. Primary completion date changed from estimate of Sep 21, 2024 to Apr 30, 2025
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Dec 12, 2024 to Sep 30, 2025
    • Site details revised at 3 of 3 sites
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
AO GENERIUM
9 trials monitored
See 1 trial at risk
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.
Trial Details
NCT Number NCT06488521
Lead Sponsor AO GENERIUM
Conditions
(from sponsor)		 Healthy Volunteers
Enrollment 256 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov