Single Dose Clinical Trial of MG-ZG122 in Chinese Healthy Adult Subjects
- Conditions
- Asthma
- Interventions
- Drug: MG-ZG122 Humanized Monoclonal Antibody InjectionDrug: Placebo
- Registration Number
- NCT05659927
- Lead Sponsor
- Shanghai Mabgeek Biotech.Co.Ltd
- Brief Summary
To determine the safety and tolerability of MG-ZG122 in Chinese healthy adult subjects
- 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).
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 34
-
- 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.
- 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);
- 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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MG-ZG122 third dose group MG-ZG122 Humanized Monoclonal Antibody Injection 10 cases in the 210 mg dose group (2 cases of placebo, 8 cases of experimental drug) MG-ZG122 first dose group MG-ZG122 Humanized Monoclonal Antibody Injection 4 cases in the 52.5 mg dose group (2 cases of placebo, 2 cases of experimental drug) MG-ZG122 first dose group Placebo 4 cases in the 52.5 mg dose group (2 cases of placebo, 2 cases of experimental drug) MG-ZG122 forth dose group Placebo 10 cases in the 420 mg dose group (2 cases of placebo, 8 cases of experimental drug) MG-ZG122 forth dose group MG-ZG122 Humanized Monoclonal Antibody Injection 10 cases in the 420 mg dose group (2 cases of placebo, 8 cases of experimental drug) MG-ZG122 second dose group MG-ZG122 Humanized Monoclonal Antibody Injection 10 cases in the 105 mg dose group (2 cases of placebo, 8 cases of experimental drug) MG-ZG122 second dose group Placebo 10 cases in the 105 mg dose group (2 cases of placebo, 8 cases of experimental drug) MG-ZG122 third dose group Placebo 10 cases in the 210 mg dose group (2 cases of placebo, 8 cases of experimental drug)
- Primary Outcome Measures
Name Time Method Tolerability and Safety Analysis up to 127 days Evaluate for dose escalation for study termination criteria or achievement of MTD
- Secondary Outcome Measures
Name Time Method Pharmacokinetic Analysis of Cmax 127 days Evaluate the pharmacokinetic parameters Cmax of MG-ZG122
Pharmacokinetic Analysis of Tmax 127 days Evaluate the pharmacokinetic parameters Tmax of MG-ZG122
Pharmacokinetic Analysis of AUC0-t 127 days Evaluate the pharmacokinetic parameters AUC0-t of MG-ZG122
Pharmacokinetic Analysis of t1/2 127 days Evaluate the pharmacokinetic parameters t1/2 of MG-ZG122
Pharmacodynamic Biomarker Analysis of immunoglobulin E 127 days The effect of MG-ZG122 was evaluated by the changes of immunoglobulin E (Immunoglobulin E, IgE) before and after administration at each follow-up time point
Pharmacodynamic Biomarker Analysis of the number of eosinophils in peripheral blood 127 days The effect of MG-ZG122 was evaluated by the changes of the number of eosinophils in peripheral blood before and after administration at each follow-up time point
Immunogenicity ADA 127 days Antidrug Antibody (ADA) Incidence (if applicable) and Their Impact on PK, Safety, and Efficacy
Neutralizing Antibody (Nab) 127 days Neutralizing Antibody (Nab) IncidenceIncidence (if applicable) and Their Impact on PK, Safety, and Efficacy
Pharmacokinetic Analysis of AUC0-∞ 127 days Evaluate the pharmacokinetic parameters AUC0-∞ of MG-ZG122
Pharmacodynamic Biomarker Analysis of serum interleukin-5 127 days The effect of MG-ZG122 was evaluated by the changes of serum interleukin-5 before and after administration at each follow-up time point
Trial Locations
- Locations (1)
The Second Affiliated Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China