NCT04653766View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

September 12, 2019

Primary Completion Date

July 18, 2020

Study Completion Date

January 4, 2023

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).

Trial Locations (1)

4000

A.T.C. Pharma, Liège

Sponsors

Lead Sponsor

Bioxodes S.A.
All Listed Sponsors
lead

Bioxodes S.A.

INDUSTRY

NCT04653766 - A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ir-CPI in Healthy Male Subjects | Biotech Hunter | Biotech Hunter