HealthyPhase 1NCT04670796
A Safety and Pharmacokinetic Study Between HLX02 and Herceptin®(US-licensed and EU-approved) in Healthy Chinese Male Subjects
A Phase 1 study testing HLX02, EU-sourced Trastuzumab (Herceptin®) and US-licensed Trastuzumab (Herceptin®) in people with Healthy, run by Shanghai Henlius Biotech at 1 site in China.
Trial summary
Randomised, double-blind, parallel group Phase I study to compare PK profiles and to assess the safety and immunogenicity between HLX02 and Herceptin® (U.S. and EU). 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
- What is being tested?
- HLX02, EU-sourced Trastuzumab (Herceptin®) and US-licensed Trastuzumab (Herceptin®)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteChina
- Study dates
- 2 Mar 2021to 4 Jun 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
- Voluntarily signed Informed Consent Form
- Healthy Chinese male (healthy is defined as the fact that no clinically significant abnormalities are identified by medical history, physical examination, vital signs, chest X ray, 12-lead ECG and laboratory tests)
- Aged ≥ 18 and ≤ 45 years
- Body mass index (BMI) ≥ 19 and ≤ 28 kg/m2
- Body weight ≥ 50 and ≤ 80 kg
- LVEF within normal range as examined through echocardiogram within 14 days prior to randomization (>50%)
- Immunogenicity (anti-drug [anti-trastuzumab] antibody [ADA]) tested as negative
- Subject agrees that he and his female spouse/partner use reliable contraceptive methods from the time of administration of study drug until 3 months after the end of study, or subject is infertile
Who cannot join
- Any clinically serious disease history or allergic disease, such as hematologic, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, mental and nervous diseases and tumor
- Use of monoclonal antibodies or any biological agent within 6 months prior to the administration of the study drug
- History of allergic reactions, including allergic reactions caused by any drug or excipient in clinical study
- Use of any prescription or non-prescription drug or dietary supplement within 5 half lives of such drug or dietary supplement or 2 weeks prior to the administration of the study drug (whichever is longer). The traditional Chinese medicine-based dietary supplement should be discontinued 28 days prior to administration of the study drug
- Donation of blood within 3 months prior to the administration of the study drug
- Participation in other clinical studies within 3 months prior to the administration of the study drug
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- Positive test result(s) for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody and treponema pallidum
- History of drug abuse
- Inability to follow the protocol requirements, instructions and study limitations as judged by investigators, such as noncooperation, inability to return to the site for follow-up visits or inability to complete the whole clinical study
- Subject confirmed SARS-CoV-2 infection by appropriate test (including but not limited to nucleic acid test) in screening period
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu
About this study
Official title: A Phase I Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity Between HLX02 and Herceptin® (US-licensed and EU-approved Reference Products, Double-blind, Randomized, Parallel-group Part) in Healthy Chinese Male Subjects
Randomised, double-blind, parallel group Phase I study to compare PK profiles and to assess the safety and immunogenicity between HLX02 and Herceptin® (U.S. and EU).
- Conditions
- Healthy
- Being tested
- HLX02, EU-sourced Trastuzumab (Herceptin®), US-licensed Trastuzumab (Herceptin®)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLX02Drug
subject receive one dose of HLX02
EU-sourced Trastuzumab (Herceptin®)Drug
subject receive one dose of EU-sourced Trastuzumab (Herceptin®)
US-licensed Trastuzumab (Herceptin®)Drug
subject receive one dose of US-licensed Trastuzumab (Herceptin®)
| Study group | Role | What they receive |
|---|---|---|
| HLX02 | Experimental | patient receive one dose of HLX02 Receives: Drug: HLX02 |
| EU-sourced Trastuzumab (Herceptin®) | Active comparator | patient receive one dose of EU-sourced Trastuzumab (Herceptin®) Receives: Drug: EU-sourced Trastuzumab (Herceptin®) |
| US-licensed Trastuzumab (Herceptin®) | Active comparator | patient receive one dose of US-licensed Trastuzumab (Herceptin®) Receives: Drug: US-licensed Trastuzumab (Herceptin®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve from time zero to infinity (AUCinf)
Measured: 57 days
Secondary outcomes (2)
Maximum serum concentration (Cmax)
Measured: 57 days
time to Cmax (Tmax)
Measured: 57 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start2 Mar 2021
- Primary completion4 Jun 2021
- Study completion4 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Henlius Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04670796
- Sponsor's protocol ID
- HLX02-HV02
- Status last verified
- Jun 2022
- First submitted
- 10 Dec 2020
- Last updated
- 3 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity Between HLX02 and Herceptin® (US-licensed and EU-approved Reference Products, Double-blind, Randomized, Parallel-group Part) in Healthy Chinese Male Subjects
- ClinicalTrials.gov ID
- NCT04670796
- Acronym / sponsor ID
- HLX02-HV02
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Shanghai Henlius BiotechIndustry (pharma, biotech, devices)
- Study start
- 2 Mar 2021 (actual)
- Primary completion
- 4 Jun 2021 (actual)
- Study completion
- 4 Jun 2021 (actual)
- First posted
- 17 Dec 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.
Randomised, double-blind, parallel group Phase I study to compare PK profiles and to assess the safety and immunogenicity between HLX02 and Herceptin® (U.S. and EU).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HLX02 | Experimental | Drug: HLX02patient receive one dose of HLX02 |
| EU-sourced Trastuzumab (Herceptin®) | Active comparator | Drug: EU-sourced Trastuzumab (Herceptin®)patient receive one dose of EU-sourced Trastuzumab (Herceptin®) |
| US-licensed Trastuzumab (Herceptin®) | Active comparator | Drug: US-licensed Trastuzumab (Herceptin®)patient receive one dose of US-licensed Trastuzumab (Herceptin®) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Voluntarily signed Informed Consent Form
- Healthy Chinese male (healthy is defined as the fact that no clinically significant abnormalities are identified by medical history, physical examination, vital signs, chest X ray, 12-lead ECG and laboratory tests)
- Aged ≥ 18 and ≤ 45 years
- Body mass index (BMI) ≥ 19 and ≤ 28 kg/m2
- Body weight ≥ 50 and ≤ 80 kg
Key exclusion criteria (10 listed)
- Any clinically serious disease history or allergic disease, such as hematologic, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, mental and nervous diseases and tumor
- Use of monoclonal antibodies or any biological agent within 6 months prior to the administration of the study drug
- History of allergic reactions, including allergic reactions caused by any drug or excipient in clinical study
- Use of any prescription or non-prescription drug or dietary supplement within 5 half lives of such drug or dietary supplement or 2 weeks prior to the administration of the study drug (whichever is longer). The traditional Chinese medicine-based dietary supplement should be discontinued 28 days prior to administration of the study drug
- Donation of blood within 3 months prior to the administration of the study drug
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 |
|---|---|---|
| HLX02subject receive one dose of HLX02 | Drug | HLX02 |
| EU-sourced Trastuzumab (Herceptin®)subject receive one dose of EU-sourced Trastuzumab (Herceptin®) | Drug | EU-sourced Trastuzumab (Herceptin®) |
| US-licensed Trastuzumab (Herceptin®)subject receive one dose of US-licensed Trastuzumab (Herceptin®) | Drug | US-licensed Trastuzumab (Herceptin®) |
Primary outcome
Area under the concentration-time curve from time zero to infinity (AUCinf)
Time frame: 57 days
2 secondary outcomes
Maximum serum concentration (Cmax)
Time frame: 57 days
time to Cmax (Tmax)
Time frame: 57 days
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 3 Jun 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 HLX02, EU-sourced Trastuzumab (Herceptin®) and US-licensed Trastuzumab (Herceptin®) in people with Healthy, 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 8 inclusion and 10 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 3 Jun 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?
Area under the concentration-time curve from time zero to infinity (AUCinf) (time frame: 57 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 3 Jun 2022.