Phase I Trial of Envafolimab for Healthy Male Subjects
NCT05849311
Phase
Phase 1
Recruitment status
Completed
Participants
Lead sponsor
3D Medicines (Sichuan) Co., Ltd.
Start date
2023-05-29
Number of sites
- 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.
- Short title
- Phase I Trial of Envafolimab for Healthy Male Subjects
- Official title
- 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
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2023-11-20
- First posted
- 2023-05-08
- Registry last updated
- 2024-08-14
- Primary completion date
- 2023-11-15
- Start date
- 2023-05-29
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- 3D Medicines (Sichuan) Co., Ltd.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05849311
- ClinicalTrials.gov ID
- NCT05849311
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Other
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
Sources for study design
AUC0-t
Timeframe: From pre-dose to day 85
Area under the plasma concentration-time curve
Cmax
Timeframe: From pre-dose to day 85
concentration
AUC0-infinity
Timeframe: From pre-dose to day 85
Area under the plasma concentration-time curve
Tmax
Timeframe: From pre-dose to day 85
Time to maximum concentration
CL
Timeframe: From pre-dose to day 85
Clearance
λz
Timeframe: From pre-dose to day 85
Apparent terminal elimination rate constant
t1/2
Timeframe: From pre-dose to day 85
Half-life (
Vd
Timeframe: From pre-dose to day 85
Volume of distribution
Safety and tolerance
Timeframe: From pre-dose to day 85
Adverse events (AE)
Immunogenicity assessment
Timeframe: From pre-dose to day 85
Anti-drug Antibody (ADA)
Sources for outcomes
- Sex
- Male
- Age groups
- Adults
- Minimum age
- 18 Years
- Maximum age
- 45 Years
- Healthy volunteers
- Yes
- 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.
- 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.
Sources for eligibility
- Beijing Gaobo Boren HosipitalBeijing, China
Sources for sites