drugset / Trial / NCT05256719

Clinical Study of Recombinant Humanized CTLA-4-FC Fusion Protein Injection in Healthy Subjects

NCT05256719 ↗

Phase 1 Unknown 46 enrolled Beijing VDJBio Co., LTD.
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

EvaluationDrugModalityDoseRoute
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.