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Clinical Study to Investigate the Safety, Tolerability, and Pharmacokinetics of GR1603 in SLE
Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd.
Summary
A Study to Investigate the Tolerability, Safety,Pharmacokinetics and efficacy of GR1603 in subjects with Systemic Lupus Erythematosus ； GR1603 injection is a monoclonal antibody targeting IFNAR1, which can block IFNAR binding to type I interferons such as IFNα and be used to treat systemic lupus erythematosus.
Official title: A Phase Ⅰb/Ⅱ, Randomized, Double-blind, Placebo-controlled Study to Investigate the Tolerability, Safety,Pharmacokinetics and Efficacy of an Intravenous Treatment Regimen of GR1603 in Subjects with Systemic Lupus Erythematosus
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
136
Start Date
2022-03-08
Completion Date
2028-10-04
Last Updated
2024-09-25
Healthy Volunteers
No
Conditions
Interventions
low dose GR1603 in phase Ⅰb
6 subjects in GR1603 low dose，2 subjects in placebo
high dose GR1603 in phaseⅠb
6 subjects in GR1603 high dose，2 subjects in placebo
low dose GR1603 in phase Ⅱ
low dose GR1603 monthly
high dose GR1603 in phase Ⅱ
high dose GR1603 monthly
Placebo in phase Ⅱ
Placebo
Locations (1)
Peking union Medical Hosipital
Beijing, Beijing Municipality, China