Similarity of Pharmacokinetics and SafetyPhase 1NCT05323981
Comparison of Pharmacokinetics and Safety of HS627(2 Specifications) Versus PERJETA With a Single Injection
A Phase 1 study testing HS627(210mg/7ml), HS627(420mg/14ml) and Perjeta in people with Similarity of Pharmacokinetics and Safety, run by BioRay Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
To evaluate the bioequivalence of HS627(2 specifications) with PERJETA in a single intravenous administration in healthy subjects 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
- Similarity of Pharmacokinetics and Safety
- What is being tested?
- HS627(210mg/7ml), HS627(420mg/14ml) and Perjeta
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 11 Apr 2022to 9 Oct 2022
- 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
- 1. Signing the informed consent and being able to complete the test according to the plan;
- 2. Aged >= 18 and <= 40 (subject to the day of signing informed consent), male;
- 3. BMI is between 20~25 kg/m2 (including 20 kg/m2 and 25 kg/m2), and the weight is between 50-70kg (including 50kg and 70kg);
- 4. The left ventricular ejection fraction (LVEF) was more than 50% by echocardiography within 2 weeks before drug administration;
- 5. During the trial period and within 6 months after the infusion, the subjects or their spouses should take appropriate and effective contraceptive measures, such as abstinence and double barrier method (such as condom and diaphragm), oral contraceptive pill and IUD placement
Who cannot join
- 1. Patients with mental, respiratory, cardiovascular, digestive, urinary, reproductive, skeletal and motor diseases, blood, endocrine, nervous and other system diseases, and the judgment of the researchers has an impact on the pharmacokinetic results or safety;
- 2. Those who have a history of allergy to pertuzumab or any of its auxiliary materials or food; or who have a history of specific allergy (asthma, urticaria, eczema dermatitis, etc.); or who are allergic to the apparatus (such as syringe needle or intravenous drip needle, or intravenous drip hose) needed in the test;
- 3.Those who have special requirements for diet and cannot follow the unified diet;
- 4.Serious bleeding factors affecting peripheral venous blood collection;
- 5. Patients with history of malignancy;
- 6. Having previously received any antibody treatment targeting HER2 receptor or used monoclonal antibody within 6 months before signing informed consent;
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- 7. Vaccinated with any live vaccine within 6 months before signing the informed consent;
- 8. Alcoholics or regular drinkers within 3 months before the test, i.e. those who drink more than 14 units of alcohol per week (14 bottles of 360 ml beer or 630 ml spirits with 40% alcohol or 2100 ml wine), or whose breath alcohol test is positive;
- 9. Have used soft drugs (such as marijuana) within 3 months before signing informed consent or hard drugs within 1 year before signing the informed consent (e.g. cocaine, phencyclidine, etc.); drug abuse test positive (morphine, Amphetamine, ketamine, dimethylene dioxoamphetamine, tetrahydrocannabinolic acid);
- 10. Within 3 months prior to signing the informed consent, he had blood donation history or lost more than 400ml of blood, received blood transfusion or had used blood products; those who lost more than 200 ml blood within one month before signing the informed consent;
- 11. Those who have participated in other clinical trials and used the experimental drugs or instruments within 3 months before signing the informed consent;
- 12. Those who are addicted to smoking or have more than 5 cigarettes per day on average within three months before signing the informed consent;
- 13. Those who have undergone surgery within 2 months before signing the informed consent;
- 14. Those who have received any drug treatment (including prescription drugs, over-the-counter drugs, biological products, proprietary Chinese medicine, vitamins, dietary supplements, etc.) and health care products within 14 days prior to signing the informed consent, or whose previous treatment drug(s) is(are) still within 5 half-lives when using the experimental drugs;
- 15. Patients with upper respiratory tract infection or other acute infections within 2 weeks before screening;
- 16. Drinking too much tea, coffee and / or caffeinated drinks (more than 8 cups, 1 cup = 250 ml) every day;
- 17. In screening or baseline period, the researchers judge that the vital signs, physical examination and laboratory examination were abnormal with clinical significance;
- 18. In screening period or baseline period, the investigator judges the ECG be clinically significantly abnormal, or QTc >= 450 ms, or with a history of clinically significant ECG abnormalities;
- 19. Any positive result of HIV antibody, HBsAg, HCV antibody and Treponema pallidum antibody;
- 20. Anti-drug antibody (ADA) test is positive;
- 21. The researcher thinks whoever is not suitable to join the group or may not be able to complete the trial due to other reasons;
- 22. Researchers, staff of research centers, sponsors and employees or related personnel of contract research organizations.
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000
About this study
Official title: A Single Center, Randomized, Double-blind, Parallel Controlled Phase I Trial Comparing the Pharmacokinetics and Safety of Two Specifications of HS627 Injection, a Recombinant Humanized Anti-Human Epidermal Growth Factor Receptor Monoclonal Antibody Injection, With PERJETA After a Single 420mg Intravenous Dose in Healthy Male Subjects
To evaluate the bioequivalence of HS627(2 specifications) with PERJETA in a single intravenous administration in healthy subjects
Read the detailed description
This is a randomized, double-blind, parallel controlled，single-dose phase I study to compare the pharmacokinetics and safety of HS627 (2 specifications) with PERJETA in Chinese healthy male adults
- Being tested
- HS627(210mg/7ml), HS627(420mg/14ml), Perjeta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS627(210mg/7ml)Drug
Intravenous drip of 420mg HS627
HS627(420mg/14ml)Drug
Intravenous drip of 420mg HS627
PerjetaDrug
Intravenous drip of 420mg PERJETA
| Study group | Role | What they receive |
|---|---|---|
| HS627(210mg/7ml) | Experimental | Not described Receives: Drug: HS627(210mg/7ml) |
| HS627(420mg/14ml) | Experimental | Not described Receives: Drug: HS627(420mg/14ml) |
| 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.
（AUC0-∞）of HS627(2 specifications) and PERJETA
Area under the concentration-time curve (AUC0 - ∞) from 0 to infinity of HS627(2 specifications) and PERJETA
Measured: 85Days
Secondary outcomes (6)
（AUC0-t）of HS627(2 specifications) and PERJETA
Area under the concentration-time curve (AUC0 - ∞) from 0 to the last measurable concentration of HS627(2 specifications) and PERJETA
Measured: 85Days
Cmax
The maximal concentration of HS627 (2 specifications) and PERJETA
Measured: 85Days
Tmax
The timepoint at which Cmax reached
Measured: 85Days
CL
Rate of plasma drug clearance
Measured: 85Days
T1/2
Half life
Measured: 85Days
Vd
Volume of distribution of HS627 (2 specifications) and PERJETA
Measured: 85Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start11 Apr 2022
- Primary completion9 Oct 2022
- Study completion9 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Similarity of Pharmacokinetics and SafetyStudies of the same condition, open and under way.
- 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
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioRay Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05323981
- Sponsor's protocol ID
- HS627-TBE
- Status last verified
- Jul 2023
- First submitted
- 5 Apr 2022
- Last updated
- 11 Jul 2023
- 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 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Randomized, Double-blind, Parallel Controlled Phase I Trial Comparing the Pharmacokinetics and Safety of Two Specifications of HS627 Injection, a Recombinant Humanized Anti-Human Epidermal Growth Factor Receptor Monoclonal Antibody Injection, With PERJETA After a Single 420mg Intravenous Dose in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT05323981
- Acronym / sponsor ID
- HS627-TBE
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- BioRay Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Apr 2022 (actual)
- Primary completion
- 9 Oct 2022 (actual)
- Study completion
- 9 Oct 2022 (actual)
- First posted
- 12 Apr 2022 (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.
To evaluate the bioequivalence of HS627(2 specifications) with PERJETA in a single intravenous administration in healthy subjects
Detailed description
This is a randomized, double-blind, parallel controlled，single-dose phase I study to compare the pharmacokinetics and safety of HS627 (2 specifications) with PERJETA in Chinese healthy male adults
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HS627(210mg/7ml) | Experimental | Drug: HS627(210mg/7ml) |
| HS627(420mg/14ml) | Experimental | Drug: HS627(420mg/14ml) |
| 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)
- 1. Signing the informed consent and being able to complete the test according to the plan;
- 2. Aged >= 18 and <= 40 (subject to the day of signing informed consent), male;
- 3. BMI is between 20~25 kg/m2 (including 20 kg/m2 and 25 kg/m2), and the weight is between 50-70kg (including 50kg and 70kg);
- 4. The left ventricular ejection fraction (LVEF) was more than 50% by echocardiography within 2 weeks before drug administration;
- 5. During the trial period and within 6 months after the infusion, the subjects or their spouses should take appropriate and effective contraceptive measures, such as abstinence and double barrier method (such as condom and diaphragm), oral contraceptive pill and IUD placement
Key exclusion criteria (22 listed)
- 1. Patients with mental, respiratory, cardiovascular, digestive, urinary, reproductive, skeletal and motor diseases, blood, endocrine, nervous and other system diseases, and the judgment of the researchers has an impact on the pharmacokinetic results or safety;
- 2. Those who have a history of allergy to pertuzumab or any of its auxiliary materials or food; or who have a history of specific allergy (asthma, urticaria, eczema dermatitis, etc.); or who are allergic to the apparatus (such as syringe needle or intravenous drip needle, or intravenous drip hose) needed in the test;
- 3.Those who have special requirements for diet and cannot follow the unified diet;
- 4.Serious bleeding factors affecting peripheral venous blood collection;
- 5. Patients with history of malignancy;
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 |
|---|---|---|
| HS627(210mg/7ml)Intravenous drip of 420mg HS627 | Drug | HS627(210mg/7ml) |
| HS627(420mg/14ml)Intravenous drip of 420mg HS627 | Drug | HS627(420mg/14ml) |
| PerjetaIntravenous drip of 420mg PERJETA | Drug | PERJETA |
Primary outcome
（AUC0-∞）of HS627(2 specifications) and PERJETA
Time frame: 85Days
Area under the concentration-time curve (AUC0 - ∞) from 0 to infinity of HS627(2 specifications) and PERJETA
6 secondary outcomes
（AUC0-t）of HS627(2 specifications) and PERJETA
Time frame: 85Days
Cmax
Time frame: 85Days
Tmax
Time frame: 85Days
CL
Time frame: 85Days
T1/2
Time frame: 85Days
Vd
Time frame: 85Days
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 Jul 2023.
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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 HS627(210mg/7ml), HS627(420mg/14ml) and Perjeta in people with Similarity of Pharmacokinetics and Safety, run by BioRay Pharmaceutical Co., Ltd. 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 22 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 Jul 2023. 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?
（AUC0-∞）of HS627(2 specifications) and PERJETA (time frame: 85Days). 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 11 Jul 2023.