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

3D Medicines (Sichuan) Co., Ltd.1 site in 1 country160 target enrollmentMay 29, 2023

ConditionsHealthy Male

InterventionsEnvafolimab with new manufacturing process Envafolimab with old manufacturing process

DrugsEnvafolimab with new manufacturing process Envafolimab with old manufacturing process

Overview

Phase: Phase 1
Intervention: Envafolimab with new manufacturing process
Conditions: Healthy Male
Sponsor: 3D Medicines (Sichuan) Co., Ltd.
Enrollment: 160
Locations: 1
Primary Endpoint: AUC0-t
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 29, 2023

End Date

November 20, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

3D Medicines (Sichuan) Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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.