NCT05918614

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

A Phase 1, Placebo-Controlled, Double-Blind Study to Examine the Safety, Tolerability, and Pharmacokinetics of 500 mg KD025 Administered Twice Daily in Healthy Male and Post-Menopausal Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (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 500 mg oral BID dose of KD025 in healthy male and post-menopausal female participants.

Detailed description

Up to approximately 58 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: 2014-03-28
• Primary completion: 2014-06-07
• Completion: 2014-06-07
• First posted: 2023-06-26
• Last updated: 2023-06-26

Locations

1 site across 1 country: United States