NCT05849311 - Phase I Trial of Envafolimab for Healthy Male Subjects | Biotech Hunter

Enrollment

160

Participants

Timeline

Start Date

May 29, 2023

Primary Completion Date

November 15, 2023

Study Completion Date

November 20, 2023

Conditions

Healthy Male

Interventions

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."

Trial Locations (1)

100070

Beijing Gaobo Boren Hosipital, Beijing