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

NCT06159101 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 304

Last updated 2023-12-06

No results posted yet for this study

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

Conditions

  • Healthy Male Volunteers

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Hu Wei · The Second Hospital of Anhui Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • China

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06159101 on ClinicalTrials.gov