Clinical Research Directory
Browse clinical research sites, groups, and studies.
Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX29 Compared With HLX11
Sponsor: Shanghai Henlius Biotech
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.
Official title: A RANDOMIZED, DOUBLE-BLIND, INTRAVENOUS SINGLE-DOSE, PARALLEL-CONTROLLED PHASE I CLINICAL STUDY TO COMPARE THE PHARMACOKINETICS, SAFETY, AND IMMUNOGENICITY OF PERTUZUMAB INJECTION BEFORE AND AFTER PROCESS CHANGE IN HEALTHY CHINESE MALE PARTICIPANTS
Key Details
Gender
MALE
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-09-05
Completion Date
2027-02-01
Last Updated
2026-08-20
Healthy Volunteers
Yes
Conditions
Interventions
HLX29
Pertuzumab injection after process change
HLX11
Pertuzumab injection before process change
Locations (1)
Anhui Medical University Second Affiliated Hospital
Hefei, Anhui, China