A Study to Determine the Effect of 500 mg Oral Dose of KD025 in Healthy Male and Post-menopausal Female Subjects

Completed · Phase 1 · Has a placebo group

Conditions studied: Immune System Disorder (Healthy Volunteer)

In brief

The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of 500 mg oral BID dose of KD025 in healthy male and post-menopausal female participants.

Key facts

Study ID

NCT05918614

Run by

Kadmon, a Sanofi Company

People needed

8

Starts

2014-03-28

Expected to finish

2014-06-07

Last updated by the study team

2023-06-26

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy participants between the ages of 18 and 55 years, inclusive.
• Female who is not of reproductive potential.
• Able to provide written informed consent prior to the performance of any study specific procedures.
• Body mass index (BMI) range of 19-30 kilogram per square meter (kg/m2), inclusive.

You may not qualify if…

• Past or present disease that is judged by the investigator to have the potential to interfere with the study procedures, compromise safety, or affect the PK evaluations.
• Known sensitivity to Rho-associated coiled-coil containing serine/threonine protein kinases (ROCK2) inhibitor agents or to any of the constituents of the KD025 formulation.
• The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.

Where it is running

• Investigational site — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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