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drugset / Trial / NCT06110338

Safety and Tolerance Study of IBI355 in Health Volunteers

NCT06110338 ↗

Phase 1 Completed 53 enrolled Innovent Biologics (Suzhou) Co. Ltd.
RandomizedSequentialDouble-blindTreatment

Summary

This study is being done to find out if IBI355 is safe and tolerance in health volunteers. The study will test increasing single doses of IBI355 given to adult health volunteers. The goal is to confirmed the safety of the highest dose of IBI355 or to find out the highest dose of IBI35 that can be given to health volunteer that dose not cause unacceptable side effects. Different dose regimens will be evaluated. The pharmacokinetics and ADA of IBI355 will also be evaluated.

Timeline

Start
2023-10-30
Primary completion
2024-09-20
Completion
2024-09-23

Drugs

EvaluationDrugModalityDoseRoute
Subject IBI355 Unknown 0.3 mg/kg Intravenous
Subject IBI355 Unknown 1 mg/kg Intravenous
Subject IBI355 Unknown 3 mg/kg Intravenous
Subject IBI355 Unknown 7.5 mg/kg Intravenous
Subject IBI355 Unknown 15 mg/kg Intravenous
Subject IBI355 Unknown 25 mg/kg Intravenous
Subject IBI355 Unknown 35 mg/kg Intravenous

Indications

No indication recorded.