drugset / Trial / NCT05679258

A Study to Compare the PK , Safety, Tolerability, and Immunogenicity of HLX15 With Daratumumab in Male Subjects

NCT05679258

Phase 1 Completed 172 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 HLX15 with Daratumumab Injection in Healthy Chinese Male Subjects

Timeline

Start
2023-01-31
Primary completion
2024-03-16
Completion
2024-06-28

Drugs

EvaluationDrugModalityDoseRoute
Comparator Daratumumab Monoclonal antibody 8 mg/kg Intravenous
Subject HLX15 Monoclonal antibody 8 mg/kg Intravenous

Indications