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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07776132




Registration number
Help: Registration number
NCT07776132
Ethics application status
Help: Ethics application status
Date submitted
Help: Date submitted
17/08/2026
Date registered
Help: Date registered
20/08/2026
Date last updated
Help: Date last updated
21/10/2026

Titles & IDs
Public title
Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX29 Compared With HLX11
Scientific 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 MALE PARTICIPANTS
Additional trial identifiers [1] 0 0
HLX29-002
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Health Adult Subjects 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Treatment: Drugs - HLX29
Treatment: Drugs - HLX11

Experimental: HLX29 - subjects will receive a single intravenous dose of HLX29

Active comparator: HLX11 - subjects will receive a single intravenous dose of HLX11


Treatment: Drugs: HLX29
Pertuzumab injection after process change

Treatment: Drugs: HLX11
Pertuzumab injection before process change
Intervention code [1] 0 0
Treatment: Drugs
Description of the comparator or control
Control group

Outcomes
Primary outcome [1] 0 0
AUC0-inf
Timepoint [1] 0 0
up to 71 days
Secondary outcome [1] 0 0
Cmax
Timepoint [1] 0 0
up to 71 days
Secondary outcome [2] 0 0
AUC0-t
Timepoint [2] 0 0
up to 71 days

Eligibility
Key inclusion criteria
1. Male subjects aged =18 and =55 years;
2. Subjects have no history of disease or past medical history abnormalities that, in the judgment of the study physician, would affect the trial;
3. Physical examination, vital signs, chest x-ray, electrocardiogram, and laboratory investigations are normal or show abnormalities without clinical significance.
4. Body mass index (BMI) =18 and =30 kg/m²;
5. Within 14 days prior to random allocation, left ventricular ejection fraction (LVEF) assessed by echocardiography is within the normal range (=55%);
Minimum age
18 Years
Maximum age
55 Years
Sex
Males
Healthy volunteers
Yes
Key exclusion criteria
1. Clinically significant diseases including but not limited to the gastrointestinal tract, kidneys, liver, nerves, blood, endocrine system, tumors, respiratory system, immune system, mental health, and cardiovascular and cerebrovascular diseases;
2. History of allergy or hypersensitivity reactions.
3. Intake of prescription drugs, over-the-counter drugs, or traditional Chinese medicine within 28 days prior to randomization;
4. History of blood donation or blood loss (>450mL) within 3 months prior to randomization;
5. Positive test results for Hepatitis B Surface Antigen (HbsAg), Hepatitis C Virus (HCV) antibodies, and Human Immunodeficiency Virus (HIV) antibodies, or abnormal and clinically significant quantitative test results for syphilis spirochetes as determined by the sub investigator;
6. History of drug abuse, substance use;
7. History of alcoholism or positive alcohol test results;
8. History of long-term heavy smoking .

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
15/11/2026
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2027
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network Pty Ltd - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Shanghai Henlius Biotech
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Joseph Taylor, Dr
Address 0 0
Nucleus Network Pty Ltd.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Iren Cheng
Address 0 0
Country 0 0
Phone 0 0
65-97503712
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT07776132