Healthy Male VolunteersPhase 1NCT04411550
Compare Pharmacokinetics, Safety, and Immunogenicity of HLX11 vs. Perjeta in Healthy Chinese Male Subjects
A Phase 1 study testing HLX11, CN-Perjeta(Pertuzumab) and EU-Perjeta(Pertuzumab) in people with Healthy Male Volunteers, run by Shanghai Henlius Biotech at 1 site in China.
Trial summary
This is a randomised, double-blind, intravenous single-dose, four-arm parallel study designed to compare the PK of HLX11 and US, EU, and CN-sourced Perjeta® in healthy Chinese adult male subjects, and to assess the safety, tolerability, and immunogenicity of these 4 drugs. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Male Volunteers
- What is being tested?
- HLX11, CN-Perjeta(Pertuzumab) and EU-Perjeta(Pertuzumab)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2020to 30 Jul 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Chinese males
- aged ≥ 18 and ≤ 45
- body mass index (BMI) ≥ 19 and ≤ 26 kg/m2
- LVEF≥ 55%
Who cannot join
- A history of any serious clinical disease such as haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, mental, neurological diseases, and tumour, or allergic diseases
- Use of a monoclonal antibody or any biological product within 6 months before study drug administration
- A history of allergic reactions or anaphylaxis, including such reactions to any drug or excipient in the clinical study
- Use of prescription drugs, over-the-counter drugs (OTC), or traditional Chinese medicine (TCM) (excluding vitamins, mineral supplements, and dietary supplements) within 28 days before study drug administration
- A history of blood donation within 3 months before study drug administration
- Participation in other clinical study and use of the investigational product/comparator within 3 months before study drug administration
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- Positive for hepatitis B surface antigen (HbsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, or treponema pallidum antibody
- A history of drug abuse
- Failure to comply with protocol requirements, instructions, and study limitations, such as uncooperative attitude, failure to return to the study site for follow-up visits, or failure to complete the entire clinical study, as judged by investigators
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A (Randomised, Double-Blind, Intravenous Single-Dose, Parallel, Four-Arm) Phase I Clinical Study to Compare Pharmacokinetics, Safety, and Immunogenicity of HLX11 vs. Perjeta® (US, EU, and CN-Sourced) in Healthy Chinese Male Subjects
This is a randomised, double-blind, intravenous single-dose, four-arm parallel study designed to compare the PK of HLX11 and US, EU, and CN-sourced Perjeta® in healthy Chinese adult male subjects, and to assess the safety, tolerability, and immunogenicity of these 4 drugs.
- Conditions
- Healthy Male Volunteers
- Being tested
- HLX11, CN-Perjeta(Pertuzumab), EU-Perjeta(Pertuzumab), US-Perjeta(Pertuzumab)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLX11Drug
healthy volunteers receive HLX11 (420mg) once
CN-Perjeta(Pertuzumab)Drug
healthy volunteers receive CN-Perjeta (420mg) once
EU-Perjeta(Pertuzumab)Drug
healthy volunteers receive EU-Perjeta (420mg) once
US-Perjeta(Pertuzumab)Drug
healthy volunteers receive US-Perjeta (420mg) once
| Study group | Role | What they receive |
|---|---|---|
| HLX11 group | Experimental | HLX11 are given intravenous infusion at a single dose of 420 mg, and the administration time is 60 min (± 10 min). Receives: Drug: HLX11 |
| CN-Perjeta group | Active comparator | CN-Perjeta are given intravenous infusion at a single dose of 420 mg, and the administration time is 60 min (± 10 min). Receives: Drug: CN-Perjeta(Pertuzumab) |
| EU-Perjeta group | Active comparator | EU-Perjeta are given intravenous infusion at a single dose of 420 mg, and the administration time is 60 min (± 10 min). Receives: Drug: EU-Perjeta(Pertuzumab) |
| US-Perjeta group | Active comparator | US-Perjeta are given intravenous infusion at a single dose of 420 mg, and the administration time is 60 min (± 10 min). Receives: Drug: US-Perjeta(Pertuzumab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Peak concentration
Measured: from predose to 2352 hours (Day 99),13 timepoints
AUC0~t
Area under the plasma concentration-time curve from time 0 to the last concentration-measurable time point
Measured: from predose to 2352 hours (Day 99),13 timepoints
AUC0~inf
Area under the plasma concentration-time curve from time 0 to infinity
Measured: from predose to 2352 hours (Day 99),13 timepoints
Secondary outcomes (3)
safety and tolerability of 4 groups
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: from day1 to day 99
safety and tolerability of 4 groups
Number of AE as assessed by CTCAE v5.0
Measured: from day1 to day 99
safety and tolerability of two groups
AE listing as assessed by CTCAE v5.0
Measured: from day1 to day 99
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start1 Jul 2020
- Primary completion1 Jul 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy Male VolunteersStudies 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
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Henlius Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wei Hu, Principal investigator, The Second Hospital of Anhui Medical UniversityHui Zhao, Principal investigator, The Second Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04411550
- Sponsor's protocol ID
- HLX11-001
- Status last verified
- Apr 2022
- First submitted
- 19 May 2020
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
American Society for Clinical Pharmacology and Therapeutics. Clin Pharmacol Ther. 2022 Mar;111 Suppl 1:S5-S80. doi: 10.1002/cpt.2521. No abstract available.
PubMed 35132630Yang J, Lin L, Long Q, Zhang Q, Sun G, Zhou L, Wang Q, Zhu J, Li F, Hu W. HLX11, a Proposed Pertuzumab Biosimilar: Pharmacokinetics, Immunogenicity, and Safety Profiles Compared to Three Reference Biologic Products (US-, EU-, and CN-Approved Pertuzumab) Administered to Healthy Male Subjects. BioDrugs. 2022 May;36(3):393-409. doi: 10.1007/s40259-022-00534-w. Epub 2022 May 20.
PubMed 35594017
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A (Randomised, Double-Blind, Intravenous Single-Dose, Parallel, Four-Arm) Phase I Clinical Study to Compare Pharmacokinetics, Safety, and Immunogenicity of HLX11 vs. Perjeta® (US, EU, and CN-Sourced) in Healthy Chinese Male Subjects
- ClinicalTrials.gov ID
- NCT04411550
- Acronym / sponsor ID
- HLX11-001
- Conditions
- Healthy Male Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Shanghai Henlius BiotechIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 2 Jun 2020 (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 randomised, double-blind, intravenous single-dose, four-arm parallel study designed to compare the PK of HLX11 and US, EU, and CN-sourced Perjeta® in healthy Chinese adult male subjects, and to assess the safety, tolerability, and immunogenicity of these 4 drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HLX11 group | Experimental | Drug: HLX11HLX11 are given intravenous infusion at a single dose of 420 mg, and the administration time is 60 min (± 10 min). |
| CN-Perjeta group | Active comparator | Drug: CN-Perjeta(Pertuzumab)CN-Perjeta are given intravenous infusion at a single dose of 420 mg, and the administration time is 60 min (± 10 min). |
| EU-Perjeta group | Active comparator | Drug: EU-Perjeta(Pertuzumab)EU-Perjeta are given intravenous infusion at a single dose of 420 mg, and the administration time is 60 min (± 10 min). |
| US-Perjeta group | Active comparator | Drug: US-Perjeta(Pertuzumab)US-Perjeta are given intravenous infusion at a single dose of 420 mg, and the administration time is 60 min (± 10 min). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy Chinese males
- aged ≥ 18 and ≤ 45
- body mass index (BMI) ≥ 19 and ≤ 26 kg/m2
- LVEF≥ 55%
Key exclusion criteria (9 listed)
- A history of any serious clinical disease such as haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, mental, neurological diseases, and tumour, or allergic diseases
- Use of a monoclonal antibody or any biological product within 6 months before study drug administration
- A history of allergic reactions or anaphylaxis, including such reactions to any drug or excipient in the clinical study
- Use of prescription drugs, over-the-counter drugs (OTC), or traditional Chinese medicine (TCM) (excluding vitamins, mineral supplements, and dietary supplements) within 28 days before study drug administration
- A history of blood donation within 3 months before study drug administration
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 |
|---|---|---|
| HLX11healthy volunteers receive HLX11 (420mg) once | Drug | HLX11 group |
| CN-Perjeta(Pertuzumab)healthy volunteers receive CN-Perjeta (420mg) once | Drug | CN-Perjeta group |
| EU-Perjeta(Pertuzumab)healthy volunteers receive EU-Perjeta (420mg) once | Drug | EU-Perjeta group |
| US-Perjeta(Pertuzumab)healthy volunteers receive US-Perjeta (420mg) once | Drug | US-Perjeta group |
Primary outcome
Cmax
Time frame: from predose to 2352 hours (Day 99),13 timepoints
Peak concentration
AUC0~t
Time frame: from predose to 2352 hours (Day 99),13 timepoints
Area under the plasma concentration-time curve from time 0 to the last concentration-measurable time point
AUC0~inf
Time frame: from predose to 2352 hours (Day 99),13 timepoints
Area under the plasma concentration-time curve from time 0 to infinity
3 secondary outcomes
safety and tolerability of 4 groups
Time frame: from day1 to day 99
safety and tolerability of 4 groups
Time frame: from day1 to day 99
safety and tolerability of two groups
Time frame: from day1 to day 99
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
- Results publication: PubMed 35132630American Society for Clinical Pharmacology and Therapeutics. Clin Pharmacol Ther. 2022 Mar;111 Suppl 1:S5-S80. doi: 10.1002/cpt.2521. No abstract available.
- Derived from this study: PubMed 35594017Yang J, Lin L, Long Q, Zhang Q, Sun G, Zhou L, Wang Q, Zhu J, Li F, Hu W. HLX11, a Proposed Pertuzumab Biosimilar: Pharmacokinetics, Immunogenicity, and Safety Profiles Compared to Three Reference Biologic Products (US-, EU-, and CN-Approved Pertuzumab) Administered to Healthy Male Subjects. BioDrugs. 2022 May;36(3):393-409. doi: 10.1007/s40259-022-00534-w. Epub 2022 May 20.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Wei Hu principal investigator
The Second Hospital of Anhui Medical University
Hui Zhao principal investigator
The Second Hospital of Anhui Medical University
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 HLX11, CN-Perjeta(Pertuzumab) and EU-Perjeta(Pertuzumab) in people with Healthy Male Volunteers, run by Shanghai Henlius Biotech at 1 site in China.
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 4 inclusion and 9 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: finished, as of the sponsor's last update on 11 May 2022. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: from predose to 2352 hours (Day 99),13 timepoints). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04411550, which also lists 2 linked publications.
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 11 May 2022.