Phase I Trial of Envafolimab for Healthy Male Subjects

Phase 1

Completed

• Conditions: Healthy Male
• Interventions: Drug: Envafolimab with old manufacturing process; Drug: Envafolimab with new manufacturing process

• Registration Number: NCT05849311
• Lead Sponsor: 3D Medicines (Sichuan) Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-27
• Study First Submitted QC: 2023-05-05
• Study First Posted: 2023-05-08
• Study Start: 2023-05-29
• Status Verified: 2023-07
• Primary Completion: 2023-11-15
• Study Completion: 2023-11-20
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Envafolimab with old manufacturing process	Envafolimab with old manufacturing process	80 healthy male subjects with Envafolimab with old manufacturing process
Envafolimab with new manufacturing process	Envafolimab with new manufacturing process	80 healthy male subjects with Envafolimab with new manufacturing process

Primary Outcome Measures

Name	Time	Method
AUC0-t	From pre-dose to day 85	Area under the plasma concentration-time curve
Cmax	From pre-dose to day 85	concentration

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Beijing Gaobo Boren Hosipital; 🇨🇳 Beijing, Beijing, China