Clinical trial NCT06277284: Clinical Study of MG-K10 Humanized Monoclonal Antibody Injection in Healthy Adult Subjects
Official title: A Randomized, Open, Parallel, Phase I Clinical Trial Comparing the Pharmacokinetics of MG-K10 Humanized Monoclonal Antibody in Healthy Adults
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pharmacokinetics
Lead sponsor: Shanghai Mabgeek Biotech.Co.Ltd
Sponsor class: OTHER_GOV
Collaborators: name: The Second Hospital of Anhui Medical University
First posted: 2024-02-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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

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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Chinese healthy adult volunteers, male or female, aged 18-50 years old (inclusive) at the time of signing the informed consent form;
3. 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;
4. 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.

Exclusion Criteria:

1. 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;
2. Those who have participated in and used the trial drug;
3. Lactating and pregnant women, or women of childbearing age volunteers with positive blood pregnancy test;
4. Had a history of dizzy with needles and blood; Or patients with orthostatic hypotension；
5. Patients who had used immunosuppressant or immunopotentiator within 3 months before drug administration;
6. There are birthmarks, scars, tattoos, open wounds at the administration site (around the umbilical cord);

Primary outcomes:
measure: Pharmacokinetic: the maximum concentration (Cmax)
timeFrame: 57 days
measure: Pharmacokinetic: area under the curve of o~t
timeFrame: 57 days
measure: Pharmacokinetic: area under the curve of o~∞
timeFrame: 57 days
Secondary outcomes:
measure: Safety evaluation index
timeFrame: 57 days
Other outcomes:
Locations:
city: Hefei
country: China
facility: The Second Affiliated Hospital of Anhui Medical University
state: Anhui
Study officials:
affiliation: The Second Hospital of Anhui Medical University
name: Wei Hu, doctor
role: STUDY_DIRECTOR
References: