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

Safety, Tolerability, and Pharmacokinetics of MG-ZG122 in a Single Subcutaneous Injection in Chinese Healthy Adult Subjects: a Single-center, Randomized, Double-blind, Placebo-controlled, Dose-increasing Phase I Clinical Trial

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

Study Overview

• Status: Active, not recruiting
• Conditions: Asthma
• Intervention / Treatment: Drug: MG-ZG122 Humanized Monoclonal Antibody Injection; Drug: Placebo

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).

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230601
      • The Second Affiliated Hospital of Anhui Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MG-ZG122 first dose group; 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; 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.; Other Names: MG-ZG122; 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.
Experimental: MG-ZG122 second dose group; 10 cases in the 105 mg dose group (2 cases of placebo, 8 cases of experimental drug)	Drug: 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.; Other Names: MG-ZG122; 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.
Experimental: MG-ZG122 third dose group; 10 cases in the 210 mg dose group (2 cases of placebo, 8 cases of experimental drug)	Drug: 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.; Other Names: MG-ZG122; 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.
Experimental: MG-ZG122 forth dose group; 10 cases in the 420 mg dose group (2 cases of placebo, 8 cases of experimental drug)	Drug: 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.; Other Names: MG-ZG122; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerability and Safety Analysis	Evaluate for dose escalation for study termination criteria or achievement of MTD	up to 127 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic Analysis of Cmax	Evaluate the pharmacokinetic parameters Cmax of MG-ZG122	127 days
Pharmacokinetic Analysis of Tmax	Evaluate the pharmacokinetic parameters Tmax of MG-ZG122	127 days
Pharmacokinetic Analysis of AUC0-t	Evaluate the pharmacokinetic parameters AUC0-t of MG-ZG122	127 days
Pharmacokinetic Analysis of t1/2	Evaluate the pharmacokinetic parameters t1/2 of MG-ZG122	127 days
Pharmacokinetic Analysis of AUC0-∞	Evaluate the pharmacokinetic parameters AUC0-∞ of MG-ZG122	127 days
Pharmacodynamic Biomarker Analysis of serum interleukin-5	The effect of MG-ZG122 was evaluated by the changes of serum interleukin-5 before and after administration at each follow-up time point	127 days
Pharmacodynamic Biomarker Analysis of immunoglobulin E	The effect of MG-ZG122 was evaluated by the changes of immunoglobulin E (Immunoglobulin E, IgE) before and after administration at each follow-up time point	127 days
Pharmacodynamic Biomarker Analysis of the number of eosinophils in peripheral blood	The effect of MG-ZG122 was evaluated by the changes of the number of eosinophils in peripheral blood before and after administration at each follow-up time point	127 days
Immunogenicity ADA	Antidrug Antibody (ADA) Incidence (if applicable) and Their Impact on PK, Safety, and Efficacy	127 days
Neutralizing Antibody (Nab)	Neutralizing Antibody (Nab) IncidenceIncidence (if applicable) and Their Impact on PK, Safety, and Efficacy	127 days

Collaborators and Investigators

• Sponsor: Shanghai Mabgeek Biotech.Co.Ltd
• Investigators: Principal Investigator: Wei Hu, The Second Hospital Of Anhui Medical University; Principal Investigator: Hui Zhao, The Second Hospital Of Anhui Medical University

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2023
• Primary Completion (Actual): January 26, 2024
• Study Completion (Estimated): March 23, 2024

Study Registration Dates

• First Submitted: November 24, 2022
• First Submitted That Met QC Criteria: December 13, 2022
• First Posted (Actual): December 21, 2022

Study Record Updates

• Last Update Posted (Estimated): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Asthma
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Immunologic Factors; Antibodies; Antibodies, Monoclonal
• Other Study ID Numbers: MG-ZG122-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We may work with other companies to develop follow-up clinical programs in China or global clinical programs

Drug and device information, study documents

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