Phase I Trial of Envafolimab for Healthy Male Subjects

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Male
• Intervention / Treatment: Drug: Envafolimab with new manufacturing process; Drug: Envafolimab with old manufacturing process

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100070
      • Beijing Gaobo Boren Hosipital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Envafolimab with new manufacturing process; 80 healthy male subjects with Envafolimab with new manufacturing process	Drug: 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.
Active Comparator: Envafolimab with old manufacturing process; 80 healthy male subjects with Envafolimab with old manufacturing process	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC0-t	Area under the plasma concentration-time curve	From pre-dose to day 85
Cmax	concentration	From pre-dose to day 85

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC0-infinity	Area under the plasma concentration-time curve	From pre-dose to day 85
Tmax	Time to maximum concentration	From pre-dose to day 85
CL	Clearance	From pre-dose to day 85
λz	Apparent terminal elimination rate constant	From pre-dose to day 85
t1/2	Half-life (	From pre-dose to day 85
Vd	Volume of distribution	From pre-dose to day 85
Safety and tolerance	Adverse events (AE)	From pre-dose to day 85
Immunogenicity assessment	Anti-drug Antibody (ADA)	From pre-dose to day 85

Collaborators and Investigators

• Sponsor: 3D Medicines (Sichuan) Co., Ltd.
• Investigators: Principal Investigator: Qing He, Beijing GoBoard Boren Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2023
• Primary Completion (Actual): November 15, 2023
• Study Completion (Actual): November 20, 2023

Study Registration Dates

• First Submitted: April 27, 2023
• First Submitted That Met QC Criteria: May 5, 2023
• First Posted (Actual): May 8, 2023

Study Record Updates

• Last Update Posted (Actual): August 14, 2024
• Last Update Submitted That Met QC Criteria: August 12, 2024
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: KN035-CN-BE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No