Phase I Trial of Envafolimab for Healthy Male Subjects

3D Medicines

Status and phase: Completed; Phase 1

Conditions: Healthy Male

Treatments: Drug: Envafolimab with new manufacturing process; Drug: Envafolimab with old manufacturing process

Study type: Interventional

Funder types: Industry

Identifiers

NCT05849311

KN035-CN-BE

Details and patient eligibility

About

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.

Enrollment: 160 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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160 participants in 2 patient groups

Envafolimab with new manufacturing process

Experimental group

Description:

80 healthy male subjects with Envafolimab with new manufacturing process

Treatment:

Drug: Envafolimab with new manufacturing process

Envafolimab with old manufacturing process

Active Comparator group

Description:

80 healthy male subjects with Envafolimab with old manufacturing process

Treatment:

Drug: Envafolimab with old manufacturing process