NCT06481215View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL
Enrollment

122

Participants

Timeline

Start Date

March 11, 2022

Primary Completion Date

September 4, 2022

Study Completion Date

December 20, 2022

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.

Trial Locations (2)

117556

"State budgetary healthcare institution of the city of Moscow City Clinic No. 2 of the Moscow Health Department", Moscow

127473

"Federal State Budgetary Educational Institution of Higher Education Moscow State Medical and Dental University named after A.I. Evdokimov of the Ministry of Health of the Russian Federation", Moscow

All Listed Sponsors
lead

AO GENERIUM

INDUSTRY