Clinical trial
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
Name
KN035-CN-BE
Description
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.
Trial arms
Trial start
2023-05-29
Estimated PCD
2023-11-23
Trial end
2024-03-01
Status
Recruiting
Phase
Early phase I
Treatment
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.
Arms:
Envafolimab with new manufacturing process
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.
Arms:
Envafolimab with old manufacturing process
Size
160
Primary endpoint
AUC0-t
From pre-dose to day 85
Cmax
From pre-dose to day 85
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 160, 'type': 'ESTIMATED'}}
Updated at
2024-01-31
1 organization
1 product
1 indication
Organization
3D MedicinesProduct
EnvafolimabIndication
Healthy Male