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

NCT05659927 | Active Not Recruiting Phase 1

• 1 other identifier: MG-ZG122-01
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Asthma

Keywords

Asthma

Outcome Measures

Primary Outcomes (1)

• Tolerability and Safety Analysis

  Evaluate for dose escalation for study termination criteria or achievement of MTD

  up to 127 days

Secondary Outcomes (10)

• Pharmacokinetic Analysis of Cmax

  127 days

• Pharmacokinetic Analysis of Tmax

  127 days

• Pharmacokinetic Analysis of AUC0-t

  127 days

• Pharmacokinetic Analysis of t1/2

  127 days

• Pharmacokinetic Analysis of AUC0-∞

  127 days

Study Arms (4)

MG-ZG122 first dose group

EXPERIMENTAL

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

Drug: MG-ZG122 Humanized Monoclonal Antibody Injection; Drug: Placebo

MG-ZG122 second dose group

EXPERIMENTAL

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

Drug: MG-ZG122 Humanized Monoclonal Antibody Injection; Drug: Placebo

MG-ZG122 third dose group

EXPERIMENTAL

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

Drug: MG-ZG122 Humanized Monoclonal Antibody Injection; Drug: Placebo

MG-ZG122 forth dose group

EXPERIMENTAL

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

Drug: MG-ZG122 Humanized Monoclonal Antibody Injection; Drug: Placebo

Interventions

MG-ZG122 Humanized Monoclonal Antibody Injection 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.

Also known as: MG-ZG122

MG-ZG122 first dose group; MG-ZG122 forth dose group; MG-ZG122 second dose group; MG-ZG122 third dose group

Placebo 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 first dose group; MG-ZG122 forth dose group; MG-ZG122 second dose group; MG-ZG122 third dose group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.
• \. 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);

You may not qualify if:

• 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;
• Those who have a history of tuberculosis infection in the past;
• The results of physical examination, vital sign measurement, laboratory examination, electrocardiogram, chest X-ray, etc. are abnormal and have clinical significance;
• 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;
• Those who have been vaccinated within 1 month before screening or plan to be vaccinated during the study;
• 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;
• 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;
• Those who have special requirements for diet or cannot accept a unified diet;
• Women who are lactating and pregnant, or female volunteers of childbearing age have a positive serum pregnancy test;

Sponsors & Collaborators

• Shanghai Mabgeek Biotech.Co.Ltd: lead

Study Sites (1)

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230601, China

Location

Related Publications (1)

• 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 Nov;34(11):943-951. doi: 10.1080/13543784.2025.2581666. Epub 2025 Oct 30.

  PMID: 41144273 DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Hui Zhao

  The Second Hospital of Anhui Medical University

  PRINCIPAL INVESTIGATOR

• Wei Hu

  The Second Hospital of Anhui Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Subcutaneous injections were 52.5 mg, 105 mg, 210 mg and 420 mg, respectively. Four patients were included in the 52.5 mg dose group (2 in the drug group and 2 in the placebo group). There were 10 cases in the other 3 dose groups (8 cases in the drug group and 2 cases in the placebo group). In accordance with the principle of dose increment, from low dose to high dose.

Study Record Dates

• First Submitted: November 24, 2022
• First Posted: December 21, 2022
• Study Start: February 9, 2023
• Primary Completion: January 26, 2024
• Study Completion: March 23, 2024
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)