Single Dose Clinical Trial of MG-ZG122 in Chinese Healthy Adult Subjects
Study Details
Study Description
Brief Summary
To determine the safety and tolerability of MG-ZG122 in Chinese healthy adult subjects
| Condition or Disease | Intervention/Treatment | 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 Design
Arms and Interventions
| 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
Single subcutaneous injection. Subjects with a dose of less than or equal to 2 ml were given one injection, and subjects with a dose of more than 2 ml were given two injections. A group 0.5 ml, B group 1 ml, C group 2 ml, D group 4 ml.
Other Names:
Drug: Placebo
Single subcutaneous injection. Subjects with a dose of less than or equal to 2 ml were given one injection, and subjects with a dose of more than 2 ml were given two injections. A group 0.5 ml, B group 1 ml, C group 2 ml, D group 4 ml.
|
| 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
Single subcutaneous injection. Subjects with a dose of less than or equal to 2 ml were given one injection, and subjects with a dose of more than 2 ml were given two injections. A group 0.5 ml, B group 1 ml, C group 2 ml, D group 4 ml.
Other Names:
Drug: Placebo
Single subcutaneous injection. Subjects with a dose of less than or equal to 2 ml were given one injection, and subjects with a dose of more than 2 ml were given two injections. A group 0.5 ml, B group 1 ml, C group 2 ml, D group 4 ml.
|
| 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
Single subcutaneous injection. Subjects with a dose of less than or equal to 2 ml were given one injection, and subjects with a dose of more than 2 ml were given two injections. A group 0.5 ml, B group 1 ml, C group 2 ml, D group 4 ml.
Other Names:
Drug: Placebo
Single subcutaneous injection. Subjects with a dose of less than or equal to 2 ml were given one injection, and subjects with a dose of more than 2 ml were given two injections. A group 0.5 ml, B group 1 ml, C group 2 ml, D group 4 ml.
|
| 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
Single subcutaneous injection. Subjects with a dose of less than or equal to 2 ml were given one injection, and subjects with a dose of more than 2 ml were given two injections. A group 0.5 ml, B group 1 ml, C group 2 ml, D group 4 ml.
Other Names:
Drug: Placebo
Single subcutaneous injection. Subjects with a dose of less than or equal to 2 ml were given one injection, and subjects with a dose of more than 2 ml were given two injections. A group 0.5 ml, B group 1 ml, C group 2 ml, D group 4 ml.
|
Outcome Measures
Primary Outcome Measures
- Tolerability and Safety Analysis [up to 127 days]
Evaluate for dose escalation for study termination criteria or achievement of MTD
Secondary Outcome Measures
- 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
- 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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
- 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);
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;
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Second Affiliated Hospital of Anhui Medical University | Hefei | Anhui | China | 230601 |
Sponsors and Collaborators
- Shanghai Mabgeek Biotech.Co.Ltd
Investigators
- Principal Investigator: Hui Zhao, The Second Hospital of Anhui Medical University
- Principal Investigator: Wei Hu, The Second Hospital of Anhui Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MG-ZG122-01