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

• Status: Not yet recruiting
• Trial end date: 2023-11-23
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Shanghai Mabgeek Biotech.Co.Ltd
• Treatments: Antibodies; Antibodies, Monoclonal

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;