> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/phase-i-trial-of-envafolimab-for-healthy-male-subjects-8ffb2150-5353-4fb3-88ab-56f6f0d2e062 > Record changed: 2026-10-13 # Phase I Trial of Envafolimab for Healthy Male Subjects NCT05849311 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05849311) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05849311) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05849311) Participants 160 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05849311) Lead sponsor 3D Medicines (Sichuan) Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05849311) Start date 2023-05-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05849311) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05849311) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05849311) **Short title** Phase I Trial of Envafolimab for Healthy Male Subjects Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05849311) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05849311) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05849311) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05849311) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05849311) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05849311) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05849311) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05849311) ## Dates **Completion date** 2023-11-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05849311) **First posted** 2023-05-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05849311) **Registry last updated** 2024-08-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05849311) **Primary completion date** 2023-11-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05849311) **Start date** 2023-05-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05849311) ## Size and sites **Actual participants** 160 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05849311) **Participants** 160 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05849311) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05849311) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05849311) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05849311) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05849311) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05849311) **Lead sponsor** 3D Medicines (Sichuan) Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05849311) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05849311) ## Identifiers **Registry ID** NCT05849311 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05849311) **ClinicalTrials.gov ID** NCT05849311 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05849311) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05849311) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Other **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05849311) ## Outcomes ### Primary outcomes 1. AUC0-t Timeframe: From pre-dose to day 85 Area under the plasma concentration-time curve 2. Cmax Timeframe: From pre-dose to day 85 concentration ### Secondary outcomes 1. AUC0-infinity Timeframe: From pre-dose to day 85 Area under the plasma concentration-time curve 2. Tmax Timeframe: From pre-dose to day 85 Time to maximum concentration 3. CL Timeframe: From pre-dose to day 85 Clearance 4. λz Timeframe: From pre-dose to day 85 Apparent terminal elimination rate constant 5. t1/2 Timeframe: From pre-dose to day 85 Half-life ( 6. Vd Timeframe: From pre-dose to day 85 Volume of distribution 7. Safety and tolerance Timeframe: From pre-dose to day 85 Adverse events (AE) 8. Immunogenicity assessment Timeframe: From pre-dose to day 85 Anti-drug Antibody (ADA) Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05849311) ## Eligibility **Sex** Male **Age groups** Adults **Minimum age** 18 Years **Maximum age** 45 Years **Healthy volunteers** Yes ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05849311) ## Sites - Beijing Gaobo Boren HosipitalBeijing, China Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05849311) ## Related records ### Drugs (1) - [Envafolimab](https://trialight.com/data/asset/envafolimab-067ce798-3523-4c36-9d89-3452238113d3.md) ### Lead sponsors (1) - [3D Medicines (Sichuan) Co., Ltd.](https://trialight.com/data/company/3d-medicines-sichuan-co-ltd-3a80dd0e-0b05-4d93-bd9e-ab835f627b5f.md) ### Targets (1) - [CD274](https://trialight.com/data/target/cd274-67467e37-9325-584a-be55-e3ef69f22b4c.md) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. 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