Shanghai Mabgeek Biotech.Co.Ltd
To determine the safety and tolerability of MG-ZG122 in Chinese healthy adult subjects
Asthma
MG-ZG122 Humanized Monoclonal Antibody Injection
Placebo
Phase 1
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 |
Estimated Enrollment : | 34 participants |
Masking: | Quadruple |
Primary Purpose: | Treatment |
Official Title: | Safety, Tolerability, and Pharmacokinetics of MG-ZG122 in a Single Subcutaneous Injection in Chinese Healthy Adult Subjects: a Single-center, Randomized, Double-blind, Placebo-controlled, Dose-increasing Phase I Clinical Trial |
Actual Study Start Date : | February 9, 2023 |
Estimated Primary Completion Date : | August 23, 2023 |
Estimated Study Completion Date : | November 23, 2023 |
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 Drug: Placebo |
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 Drug: Placebo |
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 Drug: Placebo |
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 Drug: Placebo |
Ages Eligible for Study: | 18 Years to 65 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Accepts Healthy Volunteers |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230601