drugset / Trial / NCT07495930

Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX319 Compared With EU-Phesgo®

NCT07495930 ↗

Phase 1 Not yet recruiting 24 enrolled Shanghai Henlius Biotech
RandomizedParallel-groupDouble-blindTreatment

Summary

The study is being conducted to compare the pharmacokinetic (PK) parameters of HLX319 and EU-Phesgo® after a single subcutaneous administration in healthy male subjects in China, providing a basis for the design of subsequent clinical study protocols.

Timeline

Start
2026-04-30
Primary completion
2026-07-01
Completion
2026-10-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator EU-Phesgo Monoclonal antibody — Subcutaneous
Subject HLX319 Monoclonal antibody — Subcutaneous

Indications

No indication recorded.