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NCT05659927 | Recruiting | Asthma

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

Shanghai Mabgeek Biotech.Co.Ltd

Brief Summary:

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

Condition or disease

Asthma

Intervention/treatment

MG-ZG122 Humanized Monoclonal Antibody Injection

Placebo

Phase

Phase 1

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
Estimated Enrollment : 34 participants
Masking: Quadruple
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 : February 9, 2023
Estimated Primary Completion Date : August 23, 2023
Estimated Study Completion Date : November 23, 2023
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

Drug: Placebo

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

Drug: Placebo

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

Drug: Placebo

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

Drug: Placebo
Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
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
  • 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;
Single Dose Clinical Trial of MG-ZG122 in Chinese Healthy Adult Subjects

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

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Locations

Recruiting

China, Anhui

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China, 230601