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

Shanghai Mabgeek Biotech

Status and phase: Active, not recruiting; Phase 1

Conditions: Asthma

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05659927

MG-ZG122-01

Details and patient eligibility

About

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

Full 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).

Enrollment: 34 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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34 participants in 4 patient groups

MG-ZG122 first dose group

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: MG-ZG122 Humanized Monoclonal Antibody Injection

MG-ZG122 second dose group

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: MG-ZG122 Humanized Monoclonal Antibody Injection

MG-ZG122 third dose group

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: MG-ZG122 Humanized Monoclonal Antibody Injection

MG-ZG122 forth dose group

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: MG-ZG122 Humanized Monoclonal Antibody Injection