At a glance
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A Phase I, Double Blind, Placebo Controlled, Single Ascending Dose Study of Intravenously Administered Ir-CPI to Evaluate Pharmacokinetics, Pharmacodynamics, Safety and Tolerability in Healthy Male Volunteers
In Brief
A Phase 1 clinical trial evaluating Ir-CPI - Dose 1, Ir-CPI - Dose 2, and 3 other interventions for Healthy. Completed, enrolled 32 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
6 participants received a single intravenous dose of 1.5 mg/kg of Ir-CPI during 6 hours
6 participants received a single intravenous dose of 3.0 mg/kg of Ir-CPI during 6 hours
6 participants received a single intravenous dose of 6.0 mg/kg of Ir-CPI during 6 hours
6 participants received a single intravenous dose of 9.0 mg/kg of Ir-CPI during 6 hours
For each dose group, 2 additional participants received a single intravenous dose of placebo during 6 hours (8 in total).