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A Safety and Pharmacokinetics Study of Ustekinumab Biosimilar GNR-068 and Stelara® in Healthy Volunteers

NCT06481215 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2024-07-01

No results posted yet for this study

Summary

This is a randomized open comparative parallel group study of the safety and pharmacokinetics of GNR-068 and Stelara® in healthy volunteers. Participants received a single subcutaneous dose of ustekinumab 45 mg. The follow up period was 84 days.

Conditions

  • Healthy Volunteers

Interventions

BIOLOGICAL

GNR-068

The investigational product GNR-068 was administered as a subcutaneous injection at a single dose of 45 mg.

BIOLOGICAL

Stelara®

The reference product Stelara® was administered as a subcutaneous injection at a single dose of 45 mg.

Sponsors & Collaborators

  • AO GENERIUM

    lead INDUSTRY

Principal Investigators

  • Oksana A. Markova, MD · JSC GENERIUM

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-03-11
Primary Completion
2022-09-04
Completion
2022-12-20

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 NCT06481215 on ClinicalTrials.gov