NCT05849311

Phase I Trial of Envafolimab for Healthy Male Subjects

A Randomized, Double-blind, Single-dose, Parallel Controlled Phase I Study to Evaluate the Pharmacokinetics, Safety, and Immunogenicity of Envafolimab in Healthy Male Subjects Before and After the Manufacturing Process Change

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: 3D Medicines (Sichuan) Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the pharmacokinetic similarity, safety, and immunogenicity of Envafolimab in healthy male subjects before and after the manufacturing process change.

Conditions

• Healthy Male

Interventions

Type	Name	Description
DRUG	Envafolimab with new manufacturing process	Dosage form: Envafolimab is a monoclonal antibody drug administered subcutaneously in a minimum packaging unit of 1.0 ml solution in a single-use glass vial containing a total of 200 mg of Envafolimab. Treatment method: Envafolimab, single dose, 1 mg/kg, subcutaneously.
DRUG	Envafolimab with old manufacturing process	Dosage form: Envafolimab is a monoclonal antibody drug administered subcutaneously in a minimum packaging unit of 1.0 ml solution in a single-use glass vial containing a total of 200 mg of Envafolimab. Treatment method: Envafolimab, single dose, 1 mg/kg, subcutaneously.

Timeline

• Start date: 2023-05-29
• Primary completion: 2023-11-15
• Completion: 2023-11-20
• First posted: 2023-05-08
• Last updated: 2024-08-14

Locations

1 site across 1 country: China