Phase I Trial of Envafolimab for Healthy Male Subjects

NCT ID: NCT05849311

Last Updated: 2024-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-29
• Study Completion Date: 2023-11-20

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.

Conditions

Healthy Male

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Envafolimab with new manufacturing process

80 healthy male subjects with Envafolimab with new manufacturing process

Group Type: EXPERIMENTAL

Envafolimab with new manufacturing process

Intervention Type: DRUG

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.

Envafolimab with old manufacturing process

80 healthy male subjects with Envafolimab with old manufacturing process

Group Type: ACTIVE_COMPARATOR

Envafolimab with old manufacturing process

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

3D Medicines (Sichuan) Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qing He

Role: PRINCIPAL_INVESTIGATOR

Beijing Goboard Boren Hospital

Locations

Beijing Gaobo Boren Hosipital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

KN035-CN-BE

Identifier Type: -

Identifier Source: org_study_id