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

NCT06277284 | Unknown

• 1 other identifier: MG-K10-I-002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Pharmacokinetics

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetic: the maximum concentration (Cmax)

  Concentration and exposure

  57 days

• Pharmacokinetic: area under the curve of o~t

  Concentration and exposure

  57 days

• Pharmacokinetic: area under the curve of o~∞

  Concentration and exposure

  57 days

Secondary Outcomes (1)

• Safety evaluation index

  57 days

Study Arms (2)

MG-K10 humanized monoclonal antibody injection (prefilled syringe)

EXPERIMENTAL

single injection

Drug: MG-K10 humanized monoclonal antibody injection (prefilled syringe)

MG-K10 humanized monoclonal antibody injection

ACTIVE COMPARATOR

single injection

Drug: MG-K10 humanized monoclonal antibody injection（Penicillin bottle）

Interventions

MG-K10 humanized monoclonal antibody injection (prefilled syringe) DRUG

MG-K10 Humanized Monoclonal Antibody Injection

Also known as: MG-K10 (prefilled syringe)

MG-K10 humanized monoclonal antibody injection (prefilled syringe)

MG-K10 humanized monoclonal antibody injection（Penicillin bottle） DRUG

MG-K10 humanized monoclonal antibody injection (single injection)

Also known as: MG-K10 （Penicillin bottle）

MG-K10 humanized monoclonal antibody injection

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• Shanghai Mabgeek Biotech.Co.Ltd: lead
• The Second Hospital of Anhui Medical University: collaborator

Study Sites (1)

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230061, China

Location

Study Officials

• Wei Hu, doctor

  The Second Hospital of Anhui Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: February 26, 2024
• Study Start: October 23, 2023
• Primary Completion: January 26, 2024
• Study Completion: August 1, 2024
• Last Updated: August 21, 2024

Record last verified: 2023-10

Locations

CN (1)