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

Phase 1
Active, not recruiting
Conditions
Asthma
Interventions
Drug: MG-ZG122 Humanized Monoclonal Antibody Injection
Drug: 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
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.
  1. 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;

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
MG-ZG122 third dose groupMG-ZG122 Humanized Monoclonal Antibody Injection10 cases in the 210 mg dose group (2 cases of placebo, 8 cases of experimental drug)
MG-ZG122 first dose groupMG-ZG122 Humanized Monoclonal Antibody Injection4 cases in the 52.5 mg dose group (2 cases of placebo, 2 cases of experimental drug)
MG-ZG122 first dose groupPlacebo4 cases in the 52.5 mg dose group (2 cases of placebo, 2 cases of experimental drug)
MG-ZG122 forth dose groupPlacebo10 cases in the 420 mg dose group (2 cases of placebo, 8 cases of experimental drug)
MG-ZG122 forth dose groupMG-ZG122 Humanized Monoclonal Antibody Injection10 cases in the 420 mg dose group (2 cases of placebo, 8 cases of experimental drug)
MG-ZG122 second dose groupMG-ZG122 Humanized Monoclonal Antibody Injection10 cases in the 105 mg dose group (2 cases of placebo, 8 cases of experimental drug)
MG-ZG122 second dose groupPlacebo10 cases in the 105 mg dose group (2 cases of placebo, 8 cases of experimental drug)
MG-ZG122 third dose groupPlacebo10 cases in the 210 mg dose group (2 cases of placebo, 8 cases of experimental drug)
Primary Outcome Measures
NameTimeMethod
Tolerability and Safety Analysisup to 127 days

Evaluate for dose escalation for study termination criteria or achievement of MTD

Secondary Outcome Measures
NameTimeMethod
Pharmacokinetic Analysis of Cmax127 days

Evaluate the pharmacokinetic parameters Cmax of MG-ZG122

Pharmacokinetic Analysis of Tmax127 days

Evaluate the pharmacokinetic parameters Tmax of MG-ZG122

Pharmacokinetic Analysis of AUC0-t127 days

Evaluate the pharmacokinetic parameters AUC0-t of MG-ZG122

Pharmacokinetic Analysis of t1/2127 days

Evaluate the pharmacokinetic parameters t1/2 of MG-ZG122

Pharmacodynamic Biomarker Analysis of immunoglobulin E127 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 blood127 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 ADA127 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-5127 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

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