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
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
Immunogenicity ADA 127 days Antidrug Antibody (ADA) Incidence (if applicable) and Their Impact on PK, Safety, and Efficacy
Trial Locations
- Locations (1)
The Second Affiliated Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
The Second Affiliated Hospital of Anhui Medical University🇨🇳Hefei, Anhui, China