drugset / Trial / NCT06159101

A Study to Compare the PK , Safety, Tolerability, and Immunogenicity of HLX13 With YERVOY in Male Subjects

NCT06159101

Phase 1 Unknown 304 enrolled Shanghai Henlius Biotech
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Phase I Study to Compare the Pharmacokinetic Characteristics, Safety, Tolerability, and Immunogenicity (Randomized, Double-blind, Parallel Controlled) of HLX13 with YERVOY® Injection in Healthy Chinese Male Subjects

Timeline

Start
2023-11-28
Primary completion
2024-05-28
Completion
2024-05-28

Drugs

EvaluationDrugModalityDoseRoute
Subject HLX13 Monoclonal antibody 0.3 mg/kg Intravenous
Comparator Ipilimumab Monoclonal antibody 0.3 mg/kg Intravenous

Indications

No indication recorded.