To determine the safety and tolerability of MG-ZG122 in Chinese healthy adult subjects
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
34
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.
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.
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Tolerability and Safety Analysis
Evaluate for dose escalation for study termination criteria or achievement of MTD
Time frame: up to 127 days
Pharmacokinetic Analysis of Cmax
Evaluate the pharmacokinetic parameters Cmax of MG-ZG122
Time frame: 127 days
Pharmacokinetic Analysis of Tmax
Evaluate the pharmacokinetic parameters Tmax of MG-ZG122
Time frame: 127 days
Pharmacokinetic Analysis of AUC0-t
Evaluate the pharmacokinetic parameters AUC0-t of MG-ZG122
Time frame: 127 days
Pharmacokinetic Analysis of t1/2
Evaluate the pharmacokinetic parameters t1/2 of MG-ZG122
Time frame: 127 days
Pharmacokinetic Analysis of AUC0-∞
Evaluate the pharmacokinetic parameters AUC0-∞ of MG-ZG122
Time frame: 127 days
Pharmacodynamic Biomarker Analysis of serum interleukin-5
The effect of MG-ZG122 was evaluated by the changes of serum interleukin-5 before and after administration at each follow-up time point
Time frame: 127 days
Pharmacodynamic Biomarker Analysis of immunoglobulin E
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
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Time frame: 127 days
Pharmacodynamic Biomarker Analysis of the number of eosinophils in peripheral blood
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
Time frame: 127 days
Immunogenicity ADA
Antidrug Antibody (ADA) Incidence (if applicable) and Their Impact on PK, Safety, and Efficacy
Time frame: 127 days
Neutralizing Antibody (Nab)
Neutralizing Antibody (Nab) IncidenceIncidence (if applicable) and Their Impact on PK, Safety, and Efficacy
Time frame: 127 days