Health Adult SubjectsPhase 1NCT07776132
Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX29 Compared With HLX11
A Phase 1 study testing HLX29 and HLX11 in people with Health Adult Subjects, run by Shanghai Henlius Biotech at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Health Adult Subjects
- What is being tested?
- HLX29 and HLX11
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteAustralia
- Study dates
- 15 Nov 2026to 1 Mar 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male subjects aged ≥18 and ≤55 years;
- Subjects have no history of disease or past medical history abnormalities that, in the judgment of the study physician, would affect the trial;
- Physical examination, vital signs, chest x-ray, electrocardiogram, and laboratory investigations are normal or show abnormalities without clinical significance.
- Body mass index (BMI) ≥18 and ≤30 kg/m²;
- Within 14 days prior to random allocation, left ventricular ejection fraction (LVEF) assessed by echocardiography is within the normal range (≥55%);
Who cannot join
- 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;
- History of allergy or hypersensitivity reactions.
- Intake of prescription drugs, over-the-counter drugs, or traditional Chinese medicine within 28 days prior to randomization;
- History of blood donation or blood loss (>450mL) within 3 months prior to randomization;
- 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;
- History of drug abuse, substance use;
- History of alcoholism or positive alcohol test results;
- History of long-term heavy smoking .
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site
Nucleus Network Pty Ltd
Melbourne, Victoria, 3004
Joseph Taylor, Dr, (02) 8389 0000, j.taylor3@nucleusnetwork.com.au
About this study
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 MALE PARTICIPANTS
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
- Being tested
- HLX29, HLX11
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLX29Drug
Pertuzumab injection after process change
HLX11Drug
Pertuzumab injection before process change
| Study group | Role | What they receive |
|---|---|---|
| HLX29 | Experimental | subjects will receive a single intravenous dose of HLX29 Receives: Drug: HLX29 |
| HLX11 | Active comparator | subjects will receive a single intravenous dose of HLX11 Receives: Drug: HLX11 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-inf
Area-under-curve of blood drug concentration-time from time 0 to infinity after a single drug administration
Measured: up to 71 days
Secondary outcomes (2)
Cmax
Peak concentration after a single administration
Measured: up to 71 days
AUC0-t
Area under the serum concentration-time curve from time 0 to the time of the last quantifiable concentration
Measured: up to 71 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start15 Nov 2026 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Adult SubjectsStudies of the same condition, open and under way.
- More trials run by Shanghai Henlius BiotechThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Henlius Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joseph Taylor, Dr, Study chair, Nucleus Network Pty Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07776132
- Sponsor's protocol ID
- HLX29-002
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 MALE PARTICIPANTS
- ClinicalTrials.gov ID
- NCT07776132
- Acronym / sponsor ID
- HLX29-002
- Conditions
- Health Adult Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai Henlius BiotechIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 20 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HLX29 | Experimental | Drug: HLX29subjects will receive a single intravenous dose of HLX29 |
| HLX11 | Active comparator | Drug: HLX11subjects will receive a single intravenous dose of HLX11 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male subjects aged ≥18 and ≤55 years;
- Subjects have no history of disease or past medical history abnormalities that, in the judgment of the study physician, would affect the trial;
- Physical examination, vital signs, chest x-ray, electrocardiogram, and laboratory investigations are normal or show abnormalities without clinical significance.
- Body mass index (BMI) ≥18 and ≤30 kg/m²;
- Within 14 days prior to random allocation, left ventricular ejection fraction (LVEF) assessed by echocardiography is within the normal range (≥55%);
Key exclusion criteria (8 listed)
- 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;
- History of allergy or hypersensitivity reactions.
- Intake of prescription drugs, over-the-counter drugs, or traditional Chinese medicine within 28 days prior to randomization;
- History of blood donation or blood loss (>450mL) within 3 months prior to randomization;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HLX29Pertuzumab injection after process change | Drug | HLX29 |
| HLX11Pertuzumab injection before process change | Drug | HLX11 |
Primary outcome
AUC0-inf
Time frame: up to 71 days
Area-under-curve of blood drug concentration-time from time 0 to infinity after a single drug administration
2 secondary outcomes
Cmax
Time frame: up to 71 days
AUC0-t
Time frame: up to 71 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joseph Taylor, Dr study chair
Nucleus Network Pty Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HLX29 and HLX11 in people with Health Adult Subjects, run by Shanghai Henlius Biotech at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Iren Cheng (65-97503712, irene_cheng@henlius.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC0-inf (time frame: up to 71 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.