NCT06159101

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

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 304 (estimated)
• Sponsor: Shanghai Henlius Biotech · Industry
• Sex: Male
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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

Detailed 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.

Conditions

• Healthy Male Volunteers

Interventions

Type	Name	Description
DRUG	HLX13	A single dose (0.3 mg/kg) of HLX13 via intravenous infusion.
DRUG	CN-sourced ipilimumab	A single dose (0.3 mg/kg) of CN-sourced ipilimumab via intravenous infusion.
DRUG	EU-sourced ipilimumab group	A single dose (0.3 mg/kg) of EU-sourced ipilimumab via intravenous infusion.
DRUG	US-sourced ipilimumab group	A single dose (0.3 mg/kg) of US-sourced ipilimumab via intravenous infusion.

Timeline

• Start date: 2023-11-28
• Primary completion: 2024-05-28
• Completion: 2024-05-28
• First posted: 2023-12-06
• Last updated: 2023-12-06

Locations

1 site across 1 country: China