Phase I Trial of Envafolimab for Healthy Male Subjects

Study Overview
=================
Brief 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.

Official Title
-----------------
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

Conditions
-----------------
Healthy Male

Intervention / Treatment
-----------------
* Drug: Envafolimab with new manufacturing process
* Drug: Envafolimab with old manufacturing process


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be able to fully read, understand, and sign the informed consent form; Male subjects aged 18-45 years Clinical examinations in the screening period are normal or abnormal without clinical significance; A body mass index (BMI) in the range of 19 to 26 kg/m22, and a body weight between 50 and 85 kg; Use effective contraceptive methods from the beginning of the informed consent to 5 months after the use of the drug, and have no plans to give birth or donate sperm. Exclusion Criteria: Systolic blood pressure ≥140 mmHg/ diastolic blood pressure ≥90 mmHg or systolic blood pressure < 90 mmHg/ diastolic blood pressure < 60 mmHg, pulse > 100 beats /min or < 50 beats /min at screening or baseline examination; QT interval (QTcF) ≥450; Estimated glomerular filtration rate eGFR < 90 ml/min/1.73m2; Thyroid function beyond the normal range; ALT > ULN Or AST > ULN; Prior treatment with a PD-1/L1 inhibitor; Have taken any prescription drug, over-the-counter drug, any vitamin product or herbal or health product within 14 days prior to study drug administration; Had a history of upper respiratory tract infection or other acute infection within 14 days prior to study drug administration; Positive hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus antibody or syphilis.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Envafolimab with new manufacturing process<br>80 healthy male subjects with Envafolimab with new manufacturing process | Drug: Envafolimab with new manufacturing process<br>* 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.<br>|
| Active Comparator: Envafolimab with old manufacturing process<br>80 healthy male subjects with Envafolimab with old manufacturing process | Drug: Envafolimab with old manufacturing process<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-t | Area under the plasma concentration-time curve | From pre-dose to day 85 | 
| Cmax | concentration | From pre-dose to day 85 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-infinity | Area under the plasma concentration-time curve | From pre-dose to day 85 | 
| Tmax | Time to maximum concentration | From pre-dose to day 85 | 
| CL | Clearance | From pre-dose to day 85 | 
| λz | Apparent terminal elimination rate constant | From pre-dose to day 85 | 
| t1/2 | Half-life ( | From pre-dose to day 85 | 
| Vd | Volume of distribution | From pre-dose to day 85 | 
| Safety and tolerance | Adverse events (AE) | From pre-dose to day 85 | 
| Immunogenicity assessment | Anti-drug Antibody (ADA) | From pre-dose to day 85 |