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

Healthy Male Volunteers Clinical Trial

Official title:
A Randomized, Intravenous Single-Dose, Parallel, Phase I Clinical Study to Compare the Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX13 and YERVOY® (US-, EU-, and CN-Sourced) in Healthy Chinese Male Subjects

Clinical Trial 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

Clinical Trial Description

This is a randomized, intravenous single-dose, parallel study to compare the PK characteristics of HLX13 and YERVOY® (US-, EU-, and CN-sourced) and evaluate their safety, tolerability, and immunogenicity in healthy Chinese male subjects. This study is divided into two parts. Part I is an open-label, randomized, single-dose, parallel study to compare the PK parameters of HLX13 with those of EU-sourced YERVOY® in healthy Chinese male subjects after a single intravenous infusion and provide supporting data for the design of Part II. This part of the study consists of two groups. Part II is a double-blind, randomized, single-dose, parallel study to evaluate the PK similarity of HLX 13 and YERVOY® (US-, EU-, and CN-sourced) in healthy Chinese male subjects. This part of the study consists of four groups. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06159101
Study type Interventional
Source Shanghai Henlius Biotech
Contact Hu Wei
Phone +86-0551-65997165
Status Recruiting
Phase Phase 1
Start date November 28, 2023
Completion date May 28, 2024
View Details
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