drugset / Trial / NCT05256719
Clinical Study of Recombinant Humanized CTLA-4-FC Fusion Protein Injection in Healthy Subjects
RandomizedParallel-groupDouble-blindTreatment
Summary
This is a single-center, randomized, double-blind, does-escalation Phase I Clinical Study that aim to evaluate the tolerability, safety and PK Characteristics of recombinant humanized CTLA-4-FC fusion protein injection in Healthy Subjects.
Timeline
- Start
- 2021-09-21
- Primary completion
- 2025-12-31
- Completion
- 2025-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Recombinant human CTLA-4-FC fusion protein | Protein / enzyme biologic | 1 mg/kg | Intravenous |
| Subject | Recombinant human CTLA-4-FC fusion protein | Protein / enzyme biologic | 2.5 mg/kg | Intravenous |
| Subject | Recombinant human CTLA-4-FC fusion protein | Protein / enzyme biologic | 5 mg/kg | Intravenous |
| Subject | Recombinant human CTLA-4-FC fusion protein | Protein / enzyme biologic | 7.5 mg/kg | Intravenous |
| Subject | Recombinant human CTLA-4-FC fusion protein | Protein / enzyme biologic | 10 mg/kg | Intravenous |
Indications
No indication recorded.