NCT04653766

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Bioxodes S.A. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Ir-CPI - Dose 1	6 participants received a single intravenous dose of 1.5 mg/kg of Ir-CPI during 6 hours
DRUG	Ir-CPI - Dose 2	6 participants received a single intravenous dose of 3.0 mg/kg of Ir-CPI during 6 hours
DRUG	Ir-CPI - Dose 3	6 participants received a single intravenous dose of 6.0 mg/kg of Ir-CPI during 6 hours
DRUG	Ir-CPI - Dose 4	6 participants received a single intravenous dose of 9.0 mg/kg of Ir-CPI during 6 hours
DRUG	Placebo	For each dose group, 2 additional participants received a single intravenous dose of placebo during 6 hours (8 in total).

Timeline

• Start date: 2019-09-12
• Primary completion: 2020-07-18
• Completion: 2023-01-04
• First posted: 2020-12-04
• Last updated: 2023-02-23
• Results posted: 2021-05-27

Locations

1 site across 1 country: Belgium