NCT05256719

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

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.

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Beijing VDJBio Co., LTD. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study adopts a single-center,randomized, double-blind, does-escalation, placebo-controlled design. There are five dose levels of 1mg/kg, 2.5mg/kg, 5mg/kg, 7.5mg/kg and10mg/kg. 2 of 4 subjects in the 1mg/kg dose group receive the test drug and two receive a placebo. 4 of 6 subjects in the 2.5mg/kg dose group receive the test drug and two receive a placebo. 10 of 12 subjects in the 5mg/kg dose group receive the test drug and two receive a placebo. 10 of 12 subjects in the 7.5mg/kg dose group receive the test drug and two receive a placebo. 10 of 12 subjects in the 10mg/kg dose group receive the test drug and two receive a placebo. Subjects are randomly assigned to receive intravenous administration of the test drug or placebo. The next higher dose group could be initiated only if the stopping rules is not met which are determined by investigator.

Conditions

• Health Volunteer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-09-21
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2022-02-25
• Last updated: 2024-05-07

Locations

1 site across 1 country: China