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RECRUITING
NCT05256719
PHASE1

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

Sponsor: Beijing VDJBio Co., LTD.

View on ClinicalTrials.gov

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.

Official title: a Single-Center, Randomized, Double-Blind, Does-Escalation Phase I Clinical Study to Evaluate the Tolerability, Safety, PK Characteristics of Recombinant Humanized CTLA-4-FC Fusion Protein Injection in Healthy Subjects.

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

46

Start Date

2021-09-21

Completion Date

2025-12-31

Last Updated

2024-05-07

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

Recombinant human CTLA-4-FC fusion protein for injection 1mg/kg

Recombinant human CTLA-4-FC fusion protein for injection 1mg/kg , i.v. single dose usage.

BIOLOGICAL

Recombinant human CTLA-4-FC fusion protein for injection 2.5mg/kg

Recombinant human CTLA-4-FC fusion protein for injection 2.5mg/kg , i.v. single dose usage.

BIOLOGICAL

Recombinant human CTLA-4-FC fusion protein for injection 5mg/kg

Recombinant human CTLA-4-FC fusion protein for injection 5mg/kg , i.v. single dose usage.

BIOLOGICAL

Recombinant human CTLA-4-FC fusion protein for injection 7.5mg/kg

Recombinant human CTLA-4-FC fusion protein for injection 7.5mg/kg , i.v. single dose usage.

BIOLOGICAL

Recombinant human CTLA-4-FC fusion protein for injection 10mg/kg

Recombinant human CTLA-4-FC fusion protein for injection 10mg/kg , i.v. single dose usage.

BIOLOGICAL

Placebo-1mg/kg

Recombinant human CTLA-4-FC fusion protein for injection 1mg/kg

BIOLOGICAL

Placebo-2.5mg/kg

Recombinant human CTLA-4-FC fusion protein for injection 2.5mg/kg

BIOLOGICAL

Placebo-5mg/kg

Recombinant human CTLA-4-FC fusion protein for injection 5mg/kg

BIOLOGICAL

Placebo-7.5mg/kg

Recombinant human CTLA-4-FC fusion protein for injection 7.5mg/kg

BIOLOGICAL

Placebo-10mg/kg

Recombinant human CTLA-4-FC fusion protein for injection 10mg/kg

Locations (1)

Peking University People's Hospital

Beijing, China