Single Dose Clinical Trial of MG-ZG122 in Chinese Healthy Adult Subjects

NCT ID: NCT05659927

Last Updated: 2024-02-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-09
• Study Completion Date: 2024-03-23

Brief Summary

To determine the safety and tolerability of MG-ZG122 in Chinese healthy adult subjects

Detailed Description

Main purpose: To determine the safety and tolerability of MG-ZG122 humanized monoclonal antibody injection (MG-ZG122 for short) in Chinese healthy adult subjects.

Secondary objective: To study the pharmacokinetic (PK) characteristics of MG-ZG122 in healthy Chinese adult volunteers, and to provide a basis for the design of clinical trial protocols for subsequent clinical trials; To evaluate the immunogenicity of MG-ZG122 in Chinese healthy adult volunteers; Preliminary exploration of the efficacy of MG-ZG122 in Chinese healthy adult subjects Impact of Biomarkers in Physiology (PD).

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

MG-ZG122 first dose group

4 cases in the 52.5 mg dose group (2 cases of placebo, 2 cases of experimental drug)

Group Type: EXPERIMENTAL

MG-ZG122 Humanized Monoclonal Antibody Injection

Intervention Type: DRUG

Single subcutaneous injection. Subjects with a dose of less than or equal to 2 ml were given one injection, and subjects with a dose of more than 2 ml were given two injections. A group 0.5 ml, B group 1 ml, C group 2 ml, D group 4 ml.

Placebo

Intervention Type: DRUG

Single subcutaneous injection. Subjects with a dose of less than or equal to 2 ml were given one injection, and subjects with a dose of more than 2 ml were given two injections. A group 0.5 ml, B group 1 ml, C group 2 ml, D group 4 ml.

MG-ZG122 second dose group

10 cases in the 105 mg dose group (2 cases of placebo, 8 cases of experimental drug)

Group Type: EXPERIMENTAL

MG-ZG122 Humanized Monoclonal Antibody Injection

Intervention Type: DRUG

Single subcutaneous injection. Subjects with a dose of less than or equal to 2 ml were given one injection, and subjects with a dose of more than 2 ml were given two injections. A group 0.5 ml, B group 1 ml, C group 2 ml, D group 4 ml.

Placebo

Intervention Type: DRUG

Single subcutaneous injection. Subjects with a dose of less than or equal to 2 ml were given one injection, and subjects with a dose of more than 2 ml were given two injections. A group 0.5 ml, B group 1 ml, C group 2 ml, D group 4 ml.

MG-ZG122 third dose group

10 cases in the 210 mg dose group (2 cases of placebo, 8 cases of experimental drug)

Group Type: EXPERIMENTAL

MG-ZG122 Humanized Monoclonal Antibody Injection

Intervention Type: DRUG

Single subcutaneous injection. Subjects with a dose of less than or equal to 2 ml were given one injection, and subjects with a dose of more than 2 ml were given two injections. A group 0.5 ml, B group 1 ml, C group 2 ml, D group 4 ml.

Placebo

Intervention Type: DRUG

Single subcutaneous injection. Subjects with a dose of less than or equal to 2 ml were given one injection, and subjects with a dose of more than 2 ml were given two injections. A group 0.5 ml, B group 1 ml, C group 2 ml, D group 4 ml.

MG-ZG122 forth dose group

10 cases in the 420 mg dose group (2 cases of placebo, 8 cases of experimental drug)

Group Type: EXPERIMENTAL

MG-ZG122 Humanized Monoclonal Antibody Injection

Intervention Type: DRUG

Single subcutaneous injection. Subjects with a dose of less than or equal to 2 ml were given one injection, and subjects with a dose of more than 2 ml were given two injections. A group 0.5 ml, B group 1 ml, C group 2 ml, D group 4 ml.

Placebo

Intervention Type: DRUG

Single subcutaneous injection. Subjects with a dose of less than or equal to 2 ml were given one injection, and subjects with a dose of more than 2 ml were given two injections. A group 0.5 ml, B group 1 ml, C group 2 ml, D group 4 ml.

Interventions

MG-ZG122 Humanized Monoclonal Antibody Injection

Single subcutaneous injection. Subjects with a dose of less than or equal to 2 ml were given one injection, and subjects with a dose of more than 2 ml were given two injections. A group 0.5 ml, B group 1 ml, C group 2 ml, D group 4 ml.

Intervention Type: DRUG

Placebo

Single subcutaneous injection. Subjects with a dose of less than or equal to 2 ml were given one injection, and subjects with a dose of more than 2 ml were given two injections. A group 0.5 ml, B group 1 ml, C group 2 ml, D group 4 ml.

Intervention Type: DRUG

Other Intervention Names

MG-ZG122

Eligibility Criteria

Inclusion Criteria

• 1. The subjects signed the ICF before the study and fully understood the research content, process and possible adverse reactions; voluntarily participated in the study and were able to complete the study according to the program requirements.

2. Chinese healthy adult subjects aged 18-65 years (including the boundary value) , both male and female; 3. Male volunteers weighing ≥50 kg; women weighing ≥40 kg; body mass index (BMI) within the range of 19.0-26.0 kg/m2 (including boundary values; BMI=weight kg/height 2 m2);

Exclusion Criteria

1. Patients with acute or subacute infection (such as fever, cough, urgency, dysuria, abdominal pain, diarrhea and skin infection wounds, etc.) within 2 weeks before screening, or acute or chronic infection within 4 weeks before screening history, and receiving systemic anti-infective treatment;

2. Those who have a history of tuberculosis infection in the past;

3. The results of physical examination, vital sign measurement, laboratory examination, electrocardiogram, chest X-ray, etc. are abnormal and have clinical significance;

4. Those who are known to be allergic to monoclonal antibody drugs or excipients of MG-ZG122 injection, or food allergies judged by the investigator to be unsuitable to participate in the researcher;

5. Those who have been vaccinated within 1 month before screening or plan to be vaccinated during the study;

6. Those who have used any prescription drugs within 2 weeks before administration, those who have used non-prescription drugs or traditional Chinese medicines within 1 week before administration, or those who are expected to use prescription drugs, non-prescription drugs and traditional Chinese medicines during the study period;

7. Those who have received any research non-biological agents within 5 half-lives (if known) or within 3 months (whichever is longer) before administration, or have participated in other clinical trials or plan to participate in other clinical trials during the study period. clinical trial subjects;

8. Those who have special requirements for diet or cannot accept a unified diet;

9. Women who are lactating and pregnant, or female volunteers of childbearing age have a positive serum pregnancy test;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai Mabgeek Biotech.Co.Ltd

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hui Zhao

Role: PRINCIPAL_INVESTIGATOR

The Second Hospital of Anhui Medical University

Wei Hu

Role: PRINCIPAL_INVESTIGATOR

The Second Hospital of Anhui Medical University

Locations

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Countries

China

References

Zhang X, Zhu L, Zhang Q, Zheng L, Guo J, Zou Q, Yan R, Qin D, Zhang C, Hu W. Safety, tolerability, pharmacokinetics, immunogenicity, and pharmacodynamics of MG-ZG122, a long-acting humanized anti-thymic stromal lymphopoietin mAb, in healthy Chinese: a randomized, double-blind, placebo-controlled, dose-escalation, phase I study. Expert Opin Investig Drugs. 2025 Oct 27. doi: 10.1080/13543784.2025.2581666. Online ahead of print.

Reference Type: DERIVED

PMID: 41144273 (View on PubMed)

Other Identifiers

MG-ZG122-01

Identifier Type: -

Identifier Source: org_study_id