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

NCT06481202 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2024-07-01

No results posted yet for this study

Summary

This is a randomized double-blind comparative parallel group study of the safety, pharmacokinetics and pharmacodynamics of Complarate and Actemra® in healthy volunteers. Participants received a single intravenous dose of tocilizumab 8 mg/kg. The follow up period was 43 days

Conditions

  • Healthy Volunteers

Interventions

BIOLOGICAL

Complarate®

The test drug Complarate® was administered as an intravenous infusion at a single dose of 8 mg/kg.

BIOLOGICAL

Actemra®

The reference drug Actemra® was administered as an intravenous infusion at a single dose of 8 mg/kg.

Sponsors & Collaborators

  • AO GENERIUM

    lead INDUSTRY

Principal Investigators

  • Oksana A. Markova, MD · JSC GENERIUM

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-04-11
Primary Completion
2022-06-14
Completion
2022-08-19

Countries

  • Russia

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 NCT06481202 on ClinicalTrials.gov