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Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX29 Compared With HLX11

NCT07776132 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-08-20

No results posted yet for this study

Summary

This is a randomized, double-blind, parallel-controlled study to compare the PK profile of HLX29 and HLX11 and evaluate their safety, tolerability, and immunogenicity after a single intravenous dose in healthy male adult participants.

Conditions

  • Health Adult Subjects

Interventions

DRUG

HLX29

Pertuzumab injection after process change

DRUG

HLX11

Pertuzumab injection before process change

Sponsors & Collaborators

Principal Investigators

  • Wei HU, Dr · Anhui Medical University Second Affiliated Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2026-09-05
Primary Completion
2026-12-31
Completion
2027-02-01

Countries

  • China

Study Locations

More Related Trials

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 NCT07776132 on ClinicalTrials.gov