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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Pharmacokinetics
• Intervention / Treatment: Drug: MG-K10 humanized monoclonal antibody injection (prefilled syringe); Drug: MG-K10 humanized monoclonal antibody injection（Penicillin bottle）

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230061
      • The Second Affiliated Hospital of Anhui Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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);

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MG-K10 humanized monoclonal antibody injection (prefilled syringe); single injection	Drug: MG-K10 humanized monoclonal antibody injection (prefilled syringe); MG-K10 Humanized Monoclonal Antibody Injection; Other Names: MG-K10 (prefilled syringe)
Active Comparator: MG-K10 humanized monoclonal antibody injection; single injection	Drug: MG-K10 humanized monoclonal antibody injection（Penicillin bottle）; MG-K10 humanized monoclonal antibody injection (single injection); Other Names: MG-K10 （Penicillin bottle）

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety evaluation index	Any adverse medical events that occur during a clinical study	57 days

Collaborators and Investigators

• Sponsor: Shanghai Mabgeek Biotech.Co.Ltd
• Collaborators: The Second Hospital of Anhui Medical University
• Investigators: Study Director: Wei Hu, doctor, The Second Hospital of Anhui Medical University

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2023
• Primary Completion (Actual): January 26, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: October 23, 2023
• First Submitted That Met QC Criteria: February 21, 2024
• First Posted (Actual): February 26, 2024

Study Record Updates

• Last Update Posted (Actual): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anti-Infective Agents; Antineoplastic Agents; Immunologic Factors; Anti-Bacterial Agents; Antibodies; Immunoglobulins; Antibodies, Monoclonal; Antineoplastic Agents, Immunological; Penicillins
• Other Study ID Numbers: MG-K10-I-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No