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

Study Overview
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Brief Summary
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To determine the safety and tolerability of MG-ZG122 in Chinese healthy adult subjects

Detailed Description
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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).

Official Title
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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

Conditions
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Asthma

Intervention / Treatment
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* Drug: MG-ZG122 Humanized Monoclonal Antibody Injection
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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: 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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MG-ZG122 first dose group<br>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<br>* 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.<br>* Other names: MG-ZG122;Drug: Placebo<br>* 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.<br>|
| Experimental: MG-ZG122 second dose group<br>10 cases in the 105 mg dose group (2 cases of placebo, 8 cases of experimental drug) | Drug: MG-ZG122 Humanized Monoclonal Antibody Injection<br>* 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.<br>* Other names: MG-ZG122;Drug: Placebo<br>* 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.<br>|
| Experimental: MG-ZG122 third dose group<br>10 cases in the 210 mg dose group (2 cases of placebo, 8 cases of experimental drug) | Drug: MG-ZG122 Humanized Monoclonal Antibody Injection<br>* 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.<br>* Other names: MG-ZG122;Drug: Placebo<br>* 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.<br>|
| Experimental: MG-ZG122 forth dose group<br>10 cases in the 420 mg dose group (2 cases of placebo, 8 cases of experimental drug) | Drug: MG-ZG122 Humanized Monoclonal Antibody Injection<br>* 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.<br>* Other names: MG-ZG122;Drug: Placebo<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma