drugset
drugset / Trial / NCT04868760

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

NCT04868760 ↗

Phase 1 Completed 148 enrolled Innovent Biologics (Suzhou) Co. Ltd.
RandomizedParallel-groupSingle-blindTreatment

Summary

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

Timeline

Start
2021-05-31
Primary completion
2022-05-02
Completion
2022-05-02

Drugs

EvaluationDrugModalityDoseRoute
Subject IBI310 Monoclonal antibody 0.1 mg/kg Intravenous
Subject IBI310 Monoclonal antibody 0.3 mg/kg Intravenous
Comparator Ipilimumab Monoclonal antibody 0.1 mg/kg Intravenous
Comparator Ipilimumab Monoclonal antibody 0.3 mg/kg Intravenous

Indications

No indication recorded.