drugset / Trial / NCT06484855

Safety and Tolerability of IBI355 in Patients With Primary Sjogren's Syndrome

NCT06484855 ↗

Phase 1 Completed 30 enrolled Innovent Biologics (Suzhou) Co. Ltd.
RandomizedSequentialDouble-blindTreatment

Summary

This study aims to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of IBI355 in primary Sjogren's syndrome (pSS) patients. This study also aims to evaluate the anti-Drug antibody after multiple ascending doses of IBI355 in pSS patients.

Timeline

Start
2024-07-14
Primary completion
2025-06-21
Completion
2025-07-25

Drugs

EvaluationDrugModalityDoseRoute
Subject IBI355 Unknown 7.5 mg/kg Intravenous
Subject IBI355 Unknown 15 mg/kg Intravenous
Subject IBI355 Unknown 30 mg/kg Intravenous

Indications