NCT06277284

Clinical Study of MG-K10 Humanized Monoclonal Antibody Injection in Healthy Adult Subjects

A Randomized, Open, Parallel, Phase I Clinical Trial Comparing the Pharmacokinetics of MG-K10 Humanized Monoclonal Antibody in Healthy Adults

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Shanghai Mabgeek Biotech.Co.Ltd · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Research Topics A randomized, open-label, parallel-group, phase I clinical trial comparing the pharmacokinetics of MG-K10 humanized monoclonal antibody in healthy adults

Detailed description

Objectives of the Study Main objective: To compare the pharmacokinetics of MG-K10 after a single subcutaneous injection in healthy Chinese adult subjects. Secondary objectives: To evaluate other pharmacokinetic (PK) parameters of MG-K10 after a single subcutaneous injection; The safety and tolerability of a single subcutaneous injection of MG-K10 in healthy Chinese adult subjects were evaluated. To evaluate the immunogenicity of MG-K10 in healthy Chinese adult subjects. design: The number of cases in this trial was set as 30 cases in test drug (T) group and 30 cases in control drug (R) group, and a total of 60 subjects were enrolled.

Conditions

• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	MG-K10 humanized monoclonal antibody injection (prefilled syringe)	MG-K10 Humanized Monoclonal Antibody Injection
DRUG	MG-K10 humanized monoclonal antibody injection（Penicillin bottle）	MG-K10 humanized monoclonal antibody injection (single injection)

Timeline

• Start date: 2023-10-23
• Primary completion: 2024-01-26
• Completion: 2024-08-01
• First posted: 2024-02-26
• Last updated: 2024-08-21

Locations

1 site across 1 country: China