PharmacokineticsNCT06277284
Clinical Study of MG-K10 Humanized Monoclonal Antibody Injection in Healthy Adult Subjects
A study testing MG-K10 humanized monoclonal antibody injection (prefilled syringe) and MG-K10 humanized monoclonal antibody injection（Penicillin bottle） in people with Pharmacokinetics, run by Shanghai Mabgeek Biotech.Co.Ltd at 1 site in China.
Trial summary
Research Topics A randomized, open-label, parallel-group, phase I clinical trial comparing the pharmacokinetics of MG-K10 humanized monoclonal antibody in healthy adults Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- MG-K10 humanized monoclonal antibody injection (prefilled syringe) and MG-K10 humanized monoclonal antibody injection（Penicillin bottle）
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 23 Oct 2023to Aug 2024
- Phase
- Interventional
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants signed the informed consent form before the study, and fully understood the content, process and possible adverse reactions of the study; Volunteer to participate and be able to complete the study in accordance with the protocol requirements.
- Chinese healthy adult volunteers, male or female, aged 18-50 years old (inclusive) at the time of signing the informed consent form;
- During the screening period, the body weight of male volunteers was ≥50 kg; Body weight of women ≥45 kg, and body weight of men and women must not exceed 80 kg (including 80 kg); Body mass index (BMI) in the range of 19.0-26.0kg/m2 (including the boundary value;
- From the date of signing the informed consent to 6 months after the end of the trial, the volunteers (including male volunteers) had no plans to have children and voluntarily took effective non-drug contraceptive measures, and had no plans to donate sperm or eggs.
Who cannot join
- Have any clinically serious disease history or are currently suffering from related diseases, including but not limited to diseases of the digestive system, cardiovascular system, respiratory system (such as asthma, etc.), urinary system, musculoskeletal system, endocrine system, neuropsychiatric system, blood system, immune system and other systems; Have any disorders such as coagulopathy (e.g. hemophilia) or a history of haemorrhagic diseases such as hemorrhoids, acute gastritis or gastric and duodenal ulcers; Patients with severe ocular diseases or acute ocular inflammation (conjunctivitis, blepharitis, keratitis, etc.), dry eye or pruritus; Have herpes virus infection;
- Those who have participated in and used the trial drug;
- Lactating and pregnant women, or women of childbearing age volunteers with positive blood pregnancy test;
- Had a history of dizzy with needles and blood; Or patients with orthostatic hypotension；
- Patients who had used immunosuppressant or immunopotentiator within 3 months before drug administration;
- There are birthmarks, scars, tattoos, open wounds at the administration site (around the umbilical cord);
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230061
About this study
Official title: A Randomized, Open, Parallel, Phase I Clinical Trial Comparing the Pharmacokinetics of MG-K10 Humanized Monoclonal Antibody in Healthy Adults
Research Topics A randomized, open-label, parallel-group, phase I clinical trial comparing the pharmacokinetics of MG-K10 humanized monoclonal antibody in healthy adults
Read the detailed description
Objectives of the Study
Main objective: To compare the pharmacokinetics of MG-K10 after a single subcutaneous injection in healthy Chinese adult subjects.
Secondary objectives: To evaluate other pharmacokinetic (PK) parameters of MG-K10 after a single subcutaneous injection; The safety and tolerability of a single subcutaneous injection of MG-K10 in healthy Chinese adult subjects were evaluated. To evaluate the immunogenicity of MG-K10 in healthy Chinese adult subjects.
design: The number of cases in this trial was set as 30 cases in test drug (T) group and 30 cases in control drug (R) group, and a total of 60 subjects were enrolled.
- Conditions
- Pharmacokinetics
- Being tested
- MG-K10 humanized monoclonal antibody injection (prefilled syringe), MG-K10 humanized monoclonal antibody injection（Penicillin bottle）
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MG-K10 humanized monoclonal antibody injection (prefilled syringe)Drug
Also called MG-K10 (prefilled syringe)
MG-K10 Humanized Monoclonal Antibody Injection
MG-K10 humanized monoclonal antibody injection（Penicillin bottle）Drug
Also called MG-K10 （Penicillin bottle）
MG-K10 humanized monoclonal antibody injection (single injection)
| Study group | Role | What they receive |
|---|---|---|
| MG-K10 humanized monoclonal antibody injection (prefilled syringe) | Experimental | single injection Receives: Drug: MG-K10 humanized monoclonal antibody injection (prefilled syringe) |
| MG-K10 humanized monoclonal antibody injection | Active comparator | single injection Receives: Drug: MG-K10 humanized monoclonal antibody injection（Penicillin bottle） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic: the maximum concentration (Cmax)
Concentration and exposure
Measured: 57 days
Pharmacokinetic: area under the curve of o~t
Concentration and exposure
Measured: 57 days
Pharmacokinetic: area under the curve of o~∞
Concentration and exposure
Measured: 57 days
Secondary outcomes (1)
Safety evaluation index
Any adverse medical events that occur during a clinical study
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 posted26 Feb 2024
- Study start23 Oct 2023
- Primary completion26 Jan 2024
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- More trials run by Shanghai Mabgeek Biotech.Co.LtdThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mabgeek Biotech.Co.Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Second Hospital of Anhui Medical University
- Responsible party
- Sponsor
- Investigators
- Wei Hu, doctor, Study director, The Second Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06277284
- Sponsor's protocol ID
- MG-K10-I-002
- Status last verified
- Oct 2023
- First submitted
- 23 Oct 2023
- Last updated
- 21 Aug 2024
- 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 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open, Parallel, Phase I Clinical Trial Comparing the Pharmacokinetics of MG-K10 Humanized Monoclonal Antibody in Healthy Adults
- ClinicalTrials.gov ID
- NCT06277284
- Acronym / sponsor ID
- MG-K10-I-002
- Conditions
- Pharmacokinetics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai Mabgeek Biotech.Co.LtdIndustry (pharma, biotech, devices)
- Collaborators
- The Second Hospital of Anhui Medical University
- Study start
- 23 Oct 2023 (actual)
- Primary completion
- 26 Jan 2024 (actual)
- Study completion
- Aug 2024 (estimated)
- First posted
- 26 Feb 2024 (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.
Research Topics A randomized, open-label, parallel-group, phase I clinical trial comparing the pharmacokinetics of MG-K10 humanized monoclonal antibody in healthy adults
Detailed description
Objectives of the Study
Main objective: To compare the pharmacokinetics of MG-K10 after a single subcutaneous injection in healthy Chinese adult subjects.
Secondary objectives: To evaluate other pharmacokinetic (PK) parameters of MG-K10 after a single subcutaneous injection; The safety and tolerability of a single subcutaneous injection of MG-K10 in healthy Chinese adult subjects were evaluated. To evaluate the immunogenicity of MG-K10 in healthy Chinese adult subjects.
design: The number of cases in this trial was set as 30 cases in test drug (T) group and 30 cases in control drug (R) group, and a total of 60 subjects were enrolled.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MG-K10 humanized monoclonal antibody injection (prefilled syringe) | Experimental | Drug: MG-K10 humanized monoclonal antibody injection (prefilled syringe)single injection |
| MG-K10 humanized monoclonal antibody injection | Active comparator | Drug: MG-K10 humanized monoclonal antibody injection（Penicillin bottle）single injection |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participants signed the informed consent form before the study, and fully understood the content, process and possible adverse reactions of the study; Volunteer to participate and be able to complete the study in accordance with the protocol requirements.
- Chinese healthy adult volunteers, male or female, aged 18-50 years old (inclusive) at the time of signing the informed consent form;
- During the screening period, the body weight of male volunteers was ≥50 kg; Body weight of women ≥45 kg, and body weight of men and women must not exceed 80 kg (including 80 kg); Body mass index (BMI) in the range of 19.0-26.0kg/m2 (including the boundary value;
- From the date of signing the informed consent to 6 months after the end of the trial, the volunteers (including male volunteers) had no plans to have children and voluntarily took effective non-drug contraceptive measures, and had no plans to donate sperm or eggs.
Key exclusion criteria (6 listed)
- Have any clinically serious disease history or are currently suffering from related diseases, including but not limited to diseases of the digestive system, cardiovascular system, respiratory system (such as asthma, etc.), urinary system, musculoskeletal system, endocrine system, neuropsychiatric system, blood system, immune system and other systems; Have any disorders such as coagulopathy (e.g. hemophilia) or a history of haemorrhagic diseases such as hemorrhoids, acute gastritis or gastric and duodenal ulcers; Patients with severe ocular diseases or acute ocular inflammation (conjunctivitis, blepharitis, keratitis, etc.), dry eye or pruritus; Have herpes virus infection;
- Those who have participated in and used the trial drug;
- Lactating and pregnant women, or women of childbearing age volunteers with positive blood pregnancy test;
- Had a history of dizzy with needles and blood; Or patients with orthostatic hypotension；
- Patients who had used immunosuppressant or immunopotentiator within 3 months before 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 |
|---|---|---|
| MG-K10 humanized monoclonal antibody injection (prefilled syringe)Also: MG-K10 (prefilled syringe)MG-K10 Humanized Monoclonal Antibody Injection | Drug | MG-K10 humanized monoclonal antibody injection (prefilled syringe) |
| MG-K10 humanized monoclonal antibody injection（Penicillin bottle）Also: MG-K10 （Penicillin bottle）MG-K10 humanized monoclonal antibody injection (single injection) | Drug | MG-K10 humanized monoclonal antibody injection |
Primary outcome
Pharmacokinetic: the maximum concentration (Cmax)
Time frame: 57 days
Concentration and exposure
Pharmacokinetic: area under the curve of o~t
Time frame: 57 days
Concentration and exposure
Pharmacokinetic: area under the curve of o~∞
Time frame: 57 days
Concentration and exposure
1 secondary outcome
Safety evaluation index
Time frame: 57 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
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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, doctor study director
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 study testing MG-K10 humanized monoclonal antibody injection (prefilled syringe) and MG-K10 humanized monoclonal antibody injection（Penicillin bottle） in people with Pharmacokinetics, run by Shanghai Mabgeek Biotech.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 4 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: status not confirmed, as of the sponsor's last update on 21 Aug 2024. 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.
Are results available for this study?
Results are not available in the source record.
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?
Pharmacokinetic: the maximum concentration (Cmax) (time frame: 57 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 21 Aug 2024.