Clinical Study of MG-K10 Humanized Monoclonal Antibody Injection in Healthy Adult Subjects

NCT ID: NCT06277284

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-23
• Study Completion Date: 2024-08-31

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.

Conditions

Pharmacokinetics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

MG-K10 humanized monoclonal antibody injection (prefilled syringe)

single injection

Group Type: EXPERIMENTAL

MG-K10 humanized monoclonal antibody injection (prefilled syringe)

Intervention Type: DRUG

MG-K10 Humanized Monoclonal Antibody Injection

MG-K10 humanized monoclonal antibody injection

single injection

Group Type: ACTIVE_COMPARATOR

MG-K10 humanized monoclonal antibody injection（Penicillin bottle）

Intervention Type: DRUG

MG-K10 humanized monoclonal antibody injection (single injection)

Interventions

MG-K10 humanized monoclonal antibody injection (prefilled syringe)

MG-K10 Humanized Monoclonal Antibody Injection

Intervention Type: DRUG

MG-K10 humanized monoclonal antibody injection（Penicillin bottle）

MG-K10 humanized monoclonal antibody injection (single injection)

Intervention Type: DRUG

Other Intervention Names

MG-K10 (prefilled syringe); MG-K10 （Penicillin bottle）

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);

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Second Hospital of Anhui Medical University

OTHER

Sponsor Role: collaborator

Shanghai Mabgeek Biotech.Co.Ltd

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wei Hu, doctor

Role: STUDY_DIRECTOR

The Second Hospital of Anhui Medical University

Locations

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Countries

China

Other Identifiers

MG-K10-I-002

Identifier Type: -

Identifier Source: org_study_id