Healthy VolunteersPhase 1NCT04820439
Pharmacokinetic Study of Recombinant Monoclonal Antibody Against Human Epidermal Growth Factor Receptor Injection
A Phase 1 study testing recombinant monoclonal antibody against human epidermal growth factor receptor injection (HS627) and Perjeta ® in people with Healthy Volunteers, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial summary
This study was designed as a randomized, double-blind, parallelity-controlled study.Eighty-eight healthy male subjects (44 in each group) will be enrolled in this study.The aim of this clinical trial is to evaluate pharmacokinetic similarity between recombinant monoclonal antibody against human epidermal growth factor… Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- recombinant monoclonal antibody against human epidermal growth factor receptor injection (HS627) and Perjeta ®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteChina
- Study dates
- 13 Oct 2020to 13 Mar 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male aged 18-40.
- The body mass index is in the range of 19-26 kg/m2 (including thecritical value). The weight is 50 kg-80kg.
- The subjects have no family planning within 3 months and could select contraceptive method
- The subjects who have signed the informed consent and are able to complete the experiment according to the trial protocol.
- Echocardiography showed left ventricular ejection fraction (LVEF) > 50% ,which two weeks before administration of experimental drug.
Who cannot join
- The subjects with a history of malignant tumor.
- The subjects who has received any live vaccine within 6 months prior to signing the informed consent.
- The subjects who has upper respiratory tract infection or other acute infections within the previous 2 weeks of screening.
- The subjects who had undergone surgery within 2 months prior to signing the informed consent.
- Anti-drug antibody (ADA) detection positive.
- Previous treatment with any antibody targeting the HER2 receptor or Those who have used monoclonal antibodies within 6 months prior to signing the informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetic Study of Recombinant Monoclonal Antibody Against Human Epidermal Growth Factor Receptor Injection (HS627) and Perjeta ® in Healthy Male Subjects: a Randomized, Double-blind, Parallelity-controlled Study
This study was designed as a randomized, double-blind, parallelity-controlled study.Eighty-eight healthy male subjects (44 in each group) will be enrolled in this study.The aim of this clinical trial is to evaluate pharmacokinetic similarity between recombinant monoclonal antibody against human epidermal growth factor receptor injection (HS627) and Perjeta ® in a single intravenous infusion in healthy male subjects.
- Conditions
- Healthy Volunteers
- Being tested
- recombinant monoclonal antibody against human epidermal growth factor receptor injection (HS627), Perjeta ®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant monoclonal antibody against human epidermal growth factor receptor injection (HS627)Drug
A single intravenous infusion of HS627 420mg
Perjeta ®Drug
A single intravenous infusion of Perjeta ®420mg
| Study group | Role | What they receive |
|---|---|---|
| recombinant monoclonal antibody against human epidermal growth factor receptor injection (HS627) | Experimental | Not described Receives: Drug: recombinant monoclonal antibody against human epidermal growth factor receptor injection (HS627) |
| Perjeta ® | Active comparator | Not described Receives: Drug: Perjeta ® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration versus time curve (AUC)0-∞
Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞
Measured: 150 days
Area under the plasma concentration versus time curve (AUC)0-t
Evaluation of Area under the plasma concentration versus time curve (AUC)0-t
Measured: 150 days
Peak Plasma Concentration (Cmax)
Evaluation of Peak Plasma Concentration (Cmax)
Measured: 150 days
Secondary outcomes (2)
The total clearance(CL)
Evaluation of the total clearance(CL)
Measured: 150 days
elimination half-life time(T1/2)
Evaluation of elimination half-life time(T1/2)
Measured: 150 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start13 Oct 2020
- Primary completion1 Feb 2021
- Study completion13 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by The Affiliated Hospital of Qingdao UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04820439
- Sponsor's protocol ID
- HS627-BE
- Status last verified
- Mar 2021
- First submitted
- 25 Mar 2021
- Last updated
- 29 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Study of Recombinant Monoclonal Antibody Against Human Epidermal Growth Factor Receptor Injection (HS627) and Perjeta ® in Healthy Male Subjects: a Randomized, Double-blind, Parallelity-controlled Study
- ClinicalTrials.gov ID
- NCT04820439
- Acronym / sponsor ID
- HS627-BE
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- 13 Oct 2020 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 13 Mar 2021 (actual)
- First posted
- 29 Mar 2021 (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 study was designed as a randomized, double-blind, parallelity-controlled study.Eighty-eight healthy male subjects (44 in each group) will be enrolled in this study.The aim of this clinical trial is to evaluate pharmacokinetic similarity between recombinant monoclonal antibody against human epidermal growth factor receptor injection (HS627) and Perjeta ® in a single intravenous infusion in healthy male subjects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| recombinant monoclonal antibody against human epidermal growth factor receptor injection (HS627) | Experimental | Drug: recombinant monoclonal antibody against human epidermal growth factor receptor injection (HS627) |
| Perjeta ® | Active comparator | Drug: Perjeta ® |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male aged 18-40.
- The body mass index is in the range of 19-26 kg/m2 (including thecritical value). The weight is 50 kg-80kg.
- The subjects have no family planning within 3 months and could select contraceptive method
- The subjects who have signed the informed consent and are able to complete the experiment according to the trial protocol.
- Echocardiography showed left ventricular ejection fraction (LVEF) > 50% ,which two weeks before administration of experimental drug.
Key exclusion criteria (6 listed)
- The subjects with a history of malignant tumor.
- The subjects who has received any live vaccine within 6 months prior to signing the informed consent.
- The subjects who has upper respiratory tract infection or other acute infections within the previous 2 weeks of screening.
- The subjects who had undergone surgery within 2 months prior to signing the informed consent.
- Anti-drug antibody (ADA) detection positive.
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 |
|---|---|---|
| recombinant monoclonal antibody against human epidermal growth factor receptor injection (HS627)A single intravenous infusion of HS627 420mg | Drug | recombinant monoclonal antibody against human epidermal growth factor receptor injection (HS627) |
| Perjeta ®A single intravenous infusion of Perjeta ®420mg | Drug | Perjeta ® |
Primary outcome
Area under the plasma concentration versus time curve (AUC)0-∞
Time frame: 150 days
Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞
Area under the plasma concentration versus time curve (AUC)0-t
Time frame: 150 days
Evaluation of Area under the plasma concentration versus time curve (AUC)0-t
Peak Plasma Concentration (Cmax)
Time frame: 150 days
Evaluation of Peak Plasma Concentration (Cmax)
2 secondary outcomes
The total clearance(CL)
Time frame: 150 days
elimination half-life time(T1/2)
Time frame: 150 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 29 Mar 2021.
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Screening Protocol
Pain
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 recombinant monoclonal antibody against human epidermal growth factor receptor injection (HS627) and Perjeta ® in people with Healthy Volunteers, run by The Affiliated Hospital of Qingdao University 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 5 inclusion and 6 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 29 Mar 2021. 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 plasma concentration versus time curve (AUC)0-∞ (time frame: 150 days). 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?
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 29 Mar 2021.