NCT05659927

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

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Shanghai Mabgeek Biotech.Co.Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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).

Conditions

• Asthma

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2023-02-09
• Primary completion: 2024-01-26
• Completion: 2024-03-23
• First posted: 2022-12-21
• Last updated: 2024-02-23

Locations

1 site across 1 country: China