Healthy Male
Conditions
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.
Interventions
DRUGEnvafolimab 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.
DRUGEnvafolimab 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.
Sponsors
3D Medicines (Sichuan) Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Be able to fully read, understand, and sign the informed consent form; 2. Male subjects aged 18-45 years 3. Clinical examinations in the screening period are normal or abnormal without clinical significance; 4. A body mass index (BMI) in the range of 19 to 26 kg/m22, and a body weight between 50 and 85 kg; 5. 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
1. 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; 2. QT interval (QTcF) ≥450; 3. Estimated glomerular filtration rate eGFR \< 90 ml/min/1.73m2; 4. Thyroid function beyond the normal range; 5. ALT \> ULN Or AST \> ULN; 6. Prior treatment with a PD-1/L1 inhibitor; 7. 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; 8. Had a history of upper respiratory tract infection or other acute infection within 14 days prior to study drug administration; 9. Positive hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus antibody or syphilis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC0-t | From pre-dose to day 85 | Area under the plasma concentration-time curve |
| Cmax | From pre-dose to day 85 | concentration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CL | From pre-dose to day 85 | Clearance |
| λz | From pre-dose to day 85 | Apparent terminal elimination rate constant |
| t1/2 | From pre-dose to day 85 | Half-life ( |
| AUC0-infinity | From pre-dose to day 85 | Area under the plasma concentration-time curve |
| Safety and tolerance | From pre-dose to day 85 | Adverse events (AE) |
| Immunogenicity assessment | From pre-dose to day 85 | Anti-drug Antibody (ADA) |
| Vd | From pre-dose to day 85 | Volume of distribution |
| Tmax | From pre-dose to day 85 | Time to maximum concentration |
Countries
China
Outcome results
None listed