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COMPLETED
NCT07852325
PHASE1

Comparative Pharmacokinetics of SHR-8068 and Ipilimumab in Healthy Chinese Men

Sponsor: The Affiliated Hospital of Qingdao University

View on ClinicalTrials.gov

Summary

This phase 1 study compared the pharmacokinetics of a single intravenous dose of SHR-8068 injection with ipilimumab (YERVOY®) in healthy Chinese men. Safety and immunogenicity were also evaluated.

Official title: A Single-Dose, Randomized, Double-Blind, Single-Period, Parallel Clinical Study Comparing the Pharmacokinetics of SHR-8068 Injection and Ipilimumab (YERVOY®) in Healthy Chinese Male Participants

Key Details

Gender

MALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

124

Start Date

2024-01-07

Completion Date

2024-12-19

Last Updated

2026-10-01

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

SHR-8068

SHR-8068 injection, 0.3 mg/kg, administered once by intravenous infusion over 30 ± 10 minutes.

BIOLOGICAL

Ipilimumab

Ipilimumab injection (YERVOY®), 0.3 mg/kg, administered once by intravenous infusion over 30 ± 10 minutes.

Locations (1)

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China