Phase I Trial of Envafolimab for Healthy Male Subjects

NCT05849311 | Completed Phase 1

• 1 other identifier: KN035-CN-BE
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• AUC0-t

  Area under the plasma concentration-time curve

  From pre-dose to day 85

• Cmax

  concentration

  From pre-dose to day 85

Secondary Outcomes (8)

• AUC0-infinity

  From pre-dose to day 85

• Tmax

  From pre-dose to day 85

• CL

  From pre-dose to day 85

• λz

  From pre-dose to day 85

• t1/2

  From pre-dose to day 85

Study Arms (2)

Envafolimab with new manufacturing process

EXPERIMENTAL

80 healthy male subjects with Envafolimab with new manufacturing process

Drug: Envafolimab with new manufacturing process

Envafolimab with old manufacturing process

ACTIVE COMPARATOR

80 healthy male subjects with Envafolimab with old manufacturing process

Drug: Envafolimab with old manufacturing process

Interventions

Envafolimab with new manufacturing process 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 new manufacturing process

Envafolimab with old manufacturing process 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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• 3D Medicines (Sichuan) Co., Ltd.: lead

Study Sites (1)

Beijing Gaobo Boren Hosipital

Beijing, Beijing Municipality, 100070, China

Location

MeSH Terms

Interventions

envafolimab

Study Officials

• Qing He

  Beijing Goboard Boren Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2023
• First Posted: May 8, 2023
• Study Start: May 29, 2023
• Primary Completion: November 15, 2023
• Study Completion: November 20, 2023
• Last Updated: August 14, 2024

Record last verified: 2023-07

Locations

CN (1)