NCT04868760

A Study to Evaluate the Similarity in Pharmacokinetics and Safety of IBI310 and Ipilimumab（YERVOY）in Adult Healthy Chinese Male Volunteers

Compare IBI310 and Ipilimumab on the Pharmacokinetics, Safety, Tolerance and Immunogenicity of a Single Dose In Healthy Male Subjects: a Randomized Double-blind Parallel Controlled Phase I Clinical Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 148 (actual)
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This trail will investigate the pharmacokinetics and safety of IBI310 and establish pharmacokinetics biosimilarity of IBI310 to ipilimumab （YERVOY）

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Ipilimumab	Drug: Ipilimumab 0.1 mg/kg and 0.3 mg/kg in preparatory experiments and 0.3 mg/kg in formal experiment.
DRUG	IBI310	Drug: IBI310 0.1 mg/kg and 0.3 mg/kg in preparatory experiments and 0.3 mg/kg in formal experiment.

Timeline

• Start date: 2021-05-31
• Primary completion: 2022-05-02
• Completion: 2022-05-02
• First posted: 2021-05-03
• Last updated: 2025-04-13

Locations

1 site across 1 country: China