Clinical Study of Recombinant Humanized CTLA-4-FC Fusion Protein Injection in Healthy Subjects
NCT05256719 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 46
Last updated 2024-05-07
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.
Conditions
- Health Volunteer
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
Sponsors & Collaborators
-
Beijing VDJBio Co., LTD.
lead INDUSTRY
Principal Investigators
-
Huiying Rao, M.D. · Peking University People's Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-09-21
- Primary Completion
- 2025-12-31
- Completion
- 2025-12-31
Countries
- China
Study Locations
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