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

Shanghai Mabgeek Biotech.Co.Ltd

Brief Summary:

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

Condition or disease



MG-ZG122 Humanized Monoclonal Antibody Injection




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).

Estimated Enrollment : 34 participants
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2023-02-09
Estimated Primary Completion Date : 2024-01-26
Estimated Study Completion Date : 2024-03-23

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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;

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

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China, Anhui

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China, 230601