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
PHASE1
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 : | 2023-02-09 |
Estimated Primary Completion Date : | 2024-01-26 |
Estimated Study Completion Date : | 2024-03-23 |
Information not available for Arms and Intervention/treatment
Ages Eligible for Study: | 18 Years to 65 Years |
Sexes Eligible for Study: | ALL |
Accepts Healthy Volunteers: | 1 |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
The Second Affiliated Hospital of Anhui Medical University
Fairy, Anhui, China, 230601