NCT05918588

A Study to Determine the Effect of Multiple Oral Doses and Regimens of KD025 in Healthy Male and Post-menopausal Female Subjects

A Phase 1, Placebo-Controlled, Double-Blind, Dose-Escalating Study to Examine the Safety and Tolerability of Multiple Doses of KD025 (Formerly Called SLX-2119) in Healthy Male and Post- Menopausal Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Kadmon, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of multiple oral doses and regimens of KD025 in healthy male and post-menopausal female participants.

Detailed description

Up to approximately 37 days including safety follow up period of 30 days after participant is treated with the last dose of study drug.

Conditions

• Immune System Disorder (Healthy Volunteer)

Interventions

Type	Name	Description
DRUG	Belumosudil mesylate	Pharmaceutical form: capsule; Route of administration: oral
DRUG	Placebo	Pharmaceutical form: capsule; Route of administration: oral

Timeline

• Start date: 2013-11-21
• Primary completion: 2014-03-06
• Completion: 2014-03-06
• First posted: 2023-06-26
• Last updated: 2023-06-26

Locations

1 site across 1 country: United States