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

NCT04653766 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2023-02-23

Study results available
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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

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).

Sponsors & Collaborators

  • Bioxodes S.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04653766 on ClinicalTrials.gov