Healthy VolunteersPhase 1NCT04049409
Pharmacokinetic, Safety and Immunogenicity Study of CMAB809 and Herceptin in Healthy Volunteers
A Phase 1 study testing CMAB809 and Trastuzumab in people with Healthy Volunteers, run by Taizhou Mabtech Pharmaceutical Co.,Ltd at 1 site in China.
Trial summary
This is a randomized, double-blinded, controlled Phase I study of CMAB809 administered by intravenous infusion. This study will characterize the pharmacokinetic, safety and immunogenicity of CMAB809 versus Trastuzumab(Herceptin) in healthy male subjects after a single dose. 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 Volunteers
- What is being tested?
- CMAB809 and Trastuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 17 Jun 2019to 20 Nov 2019
- 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 male volunteers, age ranged 18 to 45 years (both inclusive)
- A subject with body weight be equal or greater than 50 kg (inclusive) and body mass index (BMI) between 19 and 26 kg/m2 (both inclusive)
- Findings within the range of clinical acceptability in medical history and physical examination, and laboratory results within the laboratory reference ranges for the relevant laboratory tests (unless the investigator considers the deviation to be irrelevant for the purpose of the study)
- Left ventricular ejection fraction (LVEF) within the normal range by echocardiogram (ECHO) at 2 weeks prior to randomization
- The subjects have the ability to understand the full characteristics and objectives of the study, including the possible risks and side effects of the study; Moreover, the subjects can communicate well with researchers and complete the research according to the regulations
- Subjects must voluntarily sign ICF prior to the study
Who cannot join
- Any clinical signs and symptoms (including blood pressure, pulse, and electrocardiogram) found during medical examination; And those who underwent surgery within 4 weeks before screening; Or plans to operate during the trial period
- Diagnosed with any clinical history of serious illness or any other disease or physiological conditions which can interfere with the test results
- Prescription or over-the-counter drugs with a long half-life (greater than 24h) within 1 month prior to administration. Take any other medication that the investigator considers may affect the subject's enrollment within 2 weeks prior to administration. A subject who has participated in any other clinical trial within 3 months before the study drug administration
- Have used or are using biological products such as monoclonal antibodies or fusion proteins
- Patients who have or have had chronic hepatitis b, c, syphilis or HIV infection, or who have tested positive for the above infection were deemed unsuitable to participate in this study
- Those who had been vaccinated within 30 days prior to screening or who needed to be vaccinated between screening and the end of the trial
Show all 15Show fewer
- Drug abusers, or those who used soft drugs (e.g., marijuana) 3 months before screening, or took hard drugs (e.g., cocaine, phenyclohexidine, etc.) 1 year before the test, or drank excessive amounts of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup =250ml) every day, or those who showed positive urine drug screening
- Blood donation (containing component blood) or lost more than 400 mL of blood within 3 months before screening, or blood transfusion; Blood donation (containing component blood) or blood loss of more than 200 mL within 1 month before screening
- Related allergies (including allergy to any mouse\human protein or immunoglobulin products, rubber or latex)
- Those who smoked more than 10 cigarettes per day within 6 months before screening; And those who could not quit during the study period
- Alcoholics (who drink more than 14 standard units per week), or who have positive result in breath-test of alcohol
- Vigorous activity for 72h before drug administration; and cannot be avoided within 7 days after drug administration
- Unable to accept clinical trial center diet
- Fertile men who were unwilling to use highly effective contraceptives during the trial and for five months after administration
- The investigator judges the subject not eligible for the study after reviewing clinical laboratory results or other reasons
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Xuhui Central Hospital
Shanghai, Shanghai Municipality, 200031
About this study
Official title: A Randomized, Double-blinded, Controlled, Single Dosing Phase I Study to Investigate The Pharmacokinetic, Safety and Immunogenicity Characteristics of CMAB809 and Herceptin in Healthy Male Subjects
This is a randomized, double-blinded, controlled Phase I study of CMAB809 administered by intravenous infusion. This study will characterize the pharmacokinetic, safety and immunogenicity of CMAB809 versus Trastuzumab(Herceptin) in healthy male subjects after a single dose.
- Conditions
- Healthy Volunteers
- Being tested
- CMAB809, Trastuzumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMAB809Drug
CMAB809 will be administered by IV infusion at a single dose of 6mg/kg.
TrastuzumabDrug
Trastuzumab will be administered by IV infusion at a single dose of 6mg/kg.
| Study group | Role | What they receive |
|---|---|---|
| CMAB809 | Experimental | Not described Receives: Drug: CMAB809 |
| Trastuzumab | Active comparator | Not described Receives: Drug: Trastuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve [AUC]
Area under the concentration-time curve [AUC] from 0 to the last time point selected of CMAB809
Measured: pre-dose, hour1.5, hour3, hour8, hour24, hour48, hour96, hour168, hour336, hour504, hour672, hour1008, hour1344, hour1680 post-dose
Secondary outcomes (6)
Cmax
Maximum Serum Concentration(Cmax) of CMAB809
Measured: pre-dose, hour1.5, hour3, hour8, hour24, hour48, hour96, hour168, hour336, hour504, hour672, hour1008, hour1344, hour1680 post-dose
AUC0-∞
Area under the concentration-time curve from 0 to inf(AUC0-∞) of CMAB809
Measured: pre-dose, hour1.5, hour3, hour8, hour24, hour48, hour96, hour168, hour336, hour504, hour672, hour1008, hour1344, hour1680 post-dose
Tmax
The time of maximum blood concentration after administration(Tmax) of CMAB809
Measured: pre-dose, hour1.5, hour3, hour8, hour24, hour48, hour96, hour168, hour336, hour504, hour672, hour1008, hour1344, hour1680 post-dose
CL
Total clearance after bioavailability correction(CL) of CMAB809
Measured: pre-dose, hour1.5, hour3, hour8, hour24, hour48, hour96, hour168, hour336, hour504, hour672, hour1008, hour1344, hour1680 post-dose
T1/2
Half-life(T1/2) of CMAB809
Measured: pre-dose, hour1.5, hour3, hour8, hour24, hour48, hour96, hour168, hour336, hour504, hour672, hour1008, hour1344, hour1680 post-dose
Vd
Apparent volume of distribution corrected for bioavailability(Vd) of CMAB809
Measured: pre-dose, hour1.5, hour3, hour8, hour24, hour48, hour96, hour168, hour336, hour504, hour672, hour1008, hour1344, hour1680 post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start17 Jun 2019
- Primary completion20 Nov 2019
- Study completion20 Nov 2019
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.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taizhou Mabtech Pharmaceutical Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jingying Jia, MSC, Principal investigator, Xuhui Central Hospital, Shanghai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04049409
- Sponsor's protocol ID
- CMAB809HV-I
- Status last verified
- Oct 2020
- First submitted
- 16 Jul 2019
- Last updated
- 14 Oct 2020
- 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 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blinded, Controlled, Single Dosing Phase I Study to Investigate The Pharmacokinetic, Safety and Immunogenicity Characteristics of CMAB809 and Herceptin in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT04049409
- Acronym / sponsor ID
- CMAB809HV-I
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Taizhou Mabtech Pharmaceutical Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 17 Jun 2019 (actual)
- Primary completion
- 20 Nov 2019 (actual)
- Study completion
- 20 Nov 2019 (actual)
- First posted
- 8 Aug 2019 (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-blinded, controlled Phase I study of CMAB809 administered by intravenous infusion. This study will characterize the pharmacokinetic, safety and immunogenicity of CMAB809 versus Trastuzumab(Herceptin) in healthy male subjects after a single dose.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CMAB809 | Experimental | Drug: CMAB809 |
| Trastuzumab | Active comparator | Drug: Trastuzumab |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy male volunteers, age ranged 18 to 45 years (both inclusive)
- A subject with body weight be equal or greater than 50 kg (inclusive) and body mass index (BMI) between 19 and 26 kg/m2 (both inclusive)
- Findings within the range of clinical acceptability in medical history and physical examination, and laboratory results within the laboratory reference ranges for the relevant laboratory tests (unless the investigator considers the deviation to be irrelevant for the purpose of the study)
- Left ventricular ejection fraction (LVEF) within the normal range by echocardiogram (ECHO) at 2 weeks prior to randomization
- The subjects have the ability to understand the full characteristics and objectives of the study, including the possible risks and side effects of the study; Moreover, the subjects can communicate well with researchers and complete the research according to the regulations
Key exclusion criteria (15 listed)
- Any clinical signs and symptoms (including blood pressure, pulse, and electrocardiogram) found during medical examination; And those who underwent surgery within 4 weeks before screening; Or plans to operate during the trial period
- Diagnosed with any clinical history of serious illness or any other disease or physiological conditions which can interfere with the test results
- Prescription or over-the-counter drugs with a long half-life (greater than 24h) within 1 month prior to administration. Take any other medication that the investigator considers may affect the subject's enrollment within 2 weeks prior to administration. A subject who has participated in any other clinical trial within 3 months before the study drug administration
- Have used or are using biological products such as monoclonal antibodies or fusion proteins
- Patients who have or have had chronic hepatitis b, c, syphilis or HIV infection, or who have tested positive for the above infection were deemed unsuitable to participate in this study
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 |
|---|---|---|
| CMAB809CMAB809 will be administered by IV infusion at a single dose of 6mg/kg. | Drug | CMAB809 |
| TrastuzumabTrastuzumab will be administered by IV infusion at a single dose of 6mg/kg. | Drug | Trastuzumab |
Primary outcome
Area under the concentration-time curve [AUC]
Time frame: pre-dose, hour1.5, hour3, hour8, hour24, hour48, hour96, hour168, hour336, hour504, hour672, hour1008, hour1344, hour1680 post-dose
Area under the concentration-time curve [AUC] from 0 to the last time point selected of CMAB809
6 secondary outcomes
Cmax
Time frame: pre-dose, hour1.5, hour3, hour8, hour24, hour48, hour96, hour168, hour336, hour504, hour672, hour1008, hour1344, hour1680 post-dose
AUC0-∞
Time frame: pre-dose, hour1.5, hour3, hour8, hour24, hour48, hour96, hour168, hour336, hour504, hour672, hour1008, hour1344, hour1680 post-dose
Tmax
Time frame: pre-dose, hour1.5, hour3, hour8, hour24, hour48, hour96, hour168, hour336, hour504, hour672, hour1008, hour1344, hour1680 post-dose
CL
Time frame: pre-dose, hour1.5, hour3, hour8, hour24, hour48, hour96, hour168, hour336, hour504, hour672, hour1008, hour1344, hour1680 post-dose
T1/2
Time frame: pre-dose, hour1.5, hour3, hour8, hour24, hour48, hour96, hour168, hour336, hour504, hour672, hour1008, hour1344, hour1680 post-dose
Vd
Time frame: pre-dose, hour1.5, hour3, hour8, hour24, hour48, hour96, hour168, hour336, hour504, hour672, hour1008, hour1344, hour1680 post-dose
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 14 Oct 2020.
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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.
Jingying Jia, MSC principal investigator
Xuhui Central Hospital, Shanghai
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 CMAB809 and Trastuzumab in people with Healthy Volunteers, run by Taizhou Mabtech 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 6 inclusion and 15 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 14 Oct 2020. 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 [AUC] (time frame: pre-dose, hour1.5, hour3, hour8, hour24, hour48, hour96, hour168, hour336, hour504, hour672, hour1008, hour1344, hour1680 post-dose). 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 14 Oct 2020.