Single Dose Clinical Trial of MG-ZG122 in Chinese Healthy Adult Subjects
Asthma
About this trial
This is an interventional treatment trial for Asthma focused on measuring Asthma
Eligibility 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;
Sites / Locations
- The Second Affiliated Hospital of Anhui Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
MG-ZG122 first dose group
MG-ZG122 second dose group
MG-ZG122 third dose group
MG-ZG122 forth dose group
4 cases in the 52.5 mg dose group (2 cases of placebo, 2 cases of experimental drug)
10 cases in the 105 mg dose group (2 cases of placebo, 8 cases of experimental drug)
10 cases in the 210 mg dose group (2 cases of placebo, 8 cases of experimental drug)
10 cases in the 420 mg dose group (2 cases of placebo, 8 cases of experimental drug)