MedTrace Logo

Clinical Study to Investigate the Safety, Tolerability, and Pharmacokinetics of GR1603 in SLE

NCT06015230 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2024-09-25

No results posted yet for this study

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.

Conditions

  • Lupus Erythematosus, Systemic

Interventions

BIOLOGICAL

low dose GR1603 in phase Ⅰb

6 subjects in GR1603 low dose，2 subjects in placebo

BIOLOGICAL

high dose GR1603 in phaseⅠb

6 subjects in GR1603 high dose，2 subjects in placebo

BIOLOGICAL

low dose GR1603 in phase Ⅱ

low dose GR1603 monthly

BIOLOGICAL

high dose GR1603 in phase Ⅱ

high dose GR1603 monthly

BIOLOGICAL

Placebo in phase Ⅱ

Placebo

Sponsors & Collaborators

  • Genrix (Shanghai) Biopharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • xiaofeng zeng, PHD · Peking Union Medical College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-08
Primary Completion
2028-06-10
Completion
2028-10-04

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06015230 on ClinicalTrials.gov