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drugset / Trial / NCT04653766

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ir-CPI in Healthy Male Subjects

NCT04653766 ↗

Phase 1 Completed 32 enrolled Bioxodes S.A.
RandomizedSequentialDouble-blindOther

Summary

The purpose of this First-in-Human study is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of Ir-CPI, a novel dual inhibitor of FXIIa and FXIa, following IV administration of single ascending doses in healthy male volunteers.

Timeline

Start
2019-09-12
Primary completion
2020-07-18
Completion
2023-01-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Ir-CPI Unknown 1.5 mg/kg Intravenous
Subject Ir-CPI Unknown 3 mg/kg Intravenous
Subject Ir-CPI Unknown 6 mg/kg Intravenous
Subject Ir-CPI Unknown 9 mg/kg Intravenous

Indications

No indication recorded.