---
title: A Study to Determine the Effect of 500 mg Oral Dose of KD025 in Healthy Male and Post-menopausal Female Subjects
nct_id: NCT05918614
overall_status: COMPLETED
phase: PHASE1
sponsor: Kadmon, a Sanofi Company
study_type: INTERVENTIONAL
primary_condition: Immune System Disorder (Healthy Volunteer)
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05918614.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05918614"
ct_last_update_post_date: 2023-06-26
last_seen_at: "2026-05-12T06:40:08.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Study to Determine the Effect of 500 mg Oral Dose of KD025 in Healthy Male and Post-menopausal Female Subjects

**Official Title:** 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

**NCT ID:** [NCT05918614](https://clinicaltrials.gov/study/NCT05918614)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 8
- **Lead Sponsor:** Kadmon, a Sanofi Company
- **Conditions:** Immune System Disorder (Healthy Volunteer)
- **Start Date:** 2014-03-28
- **Completion Date:** 2014-06-07
- **CT.gov Last Update:** 2023-06-26

## Brief 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 55 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
```

## Arms

- **KD025** (EXPERIMENTAL) — 500 mg KD025 administered orally twice daily (BID) for 28 days
- **Placebo** (PLACEBO_COMPARATOR) — Placebo administered orally BID for 28 days

## Interventions

- **Belumosudil mesylate** (DRUG) — Pharmaceutical form: capsule; Route of administration: oral
- **Placebo** (DRUG) — Pharmaceutical form: capsule; Route of administration: oral

## Primary Outcomes

- **Number of participants with adverse events and serious adverse events** _(time frame: Up to approximately 58 days)_ — Number of participants with adverse events and serious adverse events

## Secondary Outcomes

- **Cmax of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)]** _(time frame: Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28)_
- **Tmax of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)]** _(time frame: Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28)_
- **Cmin of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)]** _(time frame: Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28)_
- **AUC0 -τ of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)]** _(time frame: Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28)_
- **AUCinf of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)]** _(time frame: Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28)_
- **Accumulation ratio (R) of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)]** _(time frame: Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28)_
- **t1/2 of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)]** _(time frame: Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28)_

## Locations (1)

- Investigational site, Buffalo, New York, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.investigational site|buffalo|new york|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05918614.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05918614*  
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