---
title: Phase 1 Study to Evaluate PK, Safety, and Tolerability of HRS-5041 in Healthy Caucasian Male Participants
nct_id: NCT06559007
overall_status: COMPLETED
phase: PHASE1
sponsor: Atridia Pty Ltd.
study_type: INTERVENTIONAL
primary_condition: Prostate Cancer
countries: Australia
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06559007.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06559007"
ct_last_update_post_date: 2025-03-18
last_seen_at: "2026-05-12T06:32:56.885Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Phase 1 Study to Evaluate PK, Safety, and Tolerability of HRS-5041 in Healthy Caucasian Male Participants

**Official Title:** A Phase 1, Open-Label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Single Dose HRS-5041 in Healthy Caucasian Male Participants

**NCT ID:** [NCT06559007](https://clinicaltrials.gov/study/NCT06559007)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 24
- **Lead Sponsor:** Atridia Pty Ltd.
- **Conditions:** Prostate Cancer
- **Start Date:** 2024-09-25
- **Completion Date:** 2025-03-03
- **CT.gov Last Update:** 2025-03-18

## Brief Summary

This is a phase 1, open-label, randomized study. The objective of this study is to evaluate the PK, safety and tolerability of orally administered single-dose HRS-5041 in healthy Caucasian male participants.

## Detailed Description

The objective of this study is to evaluate the PK, safety and tolerability of orally administered single-dose HRS-5041 in healthy Caucasian male participants.

## Eligibility

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

```
Inclusion Criteria:

1. Healthy Caucasian participants;
2. Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial,
3. Male aged between 18 to 55 years of age (inclusive) at the date of signed consent form.
4. Total body weight ≥ 50.0 kg, body mass index (BMI) between 19.0 and 32.0 kg/m2 (inclusive) at screening.

Exclusion Criteria:

1. History of receiving any androgen receptor (AR) degraders.
2. History or evidence of clinically significant
3. History of severe abnormal gastric emptying, severe gastrointestinal (GI) disease, or participants who had GI surgeries (except GI polypectomy).
4. Severe infections, injuries, or major surgeries as determined by the investigator within 6 months
5. Any other circumstances (e.g., not suitable for venous access) or laboratory abnormality that, in the investigator's judgment, may increase the risk to the participant, or be associated with the participant's participation in and completion of the study or could preclude the evaluation of the participant's response.
```

## Arms

- **Experimental: HRS-5041 dose level 1** (EXPERIMENTAL) — Sing dose level 1
- **Experimental: HRS-5041 dose level 2** (EXPERIMENTAL) — Sing dose level 2

## Interventions

- **HRS-5041 dose level 1** (DRUG) — Single dose of HRS-5041 orally administered
- **HRS-5041 dose level 2** (DRUG) — Single dose of HRS-5041 orally administered

## Primary Outcomes

- **PK profile (Cmax) of HRS-5041 after a single oral (PO) administration:** _(time frame: Day 10)_ — Parameters: Cmax
- **PK profile (AUC0-t) of HRS-5041 after a single oral (PO) administration:** _(time frame: Day 10)_ — Parameter: AUC0-t
- **PK profile (AUC0-inf) of HRS-5041 after a single oral (PO) administration:** _(time frame: Day 10)_ — Parameter:AUC0-inf
- **PK profile (Tmax) of HRS-5041 after a single oral (PO) administration:** _(time frame: Day 10)_ — Parameter: Tmax
- **PK profile ( t1/2) of HRS-5041 after a single oral (PO) administration:** _(time frame: Day 10)_ — Parameter: t1/2
- **PK profile (CL/F) of HRS-5041 after a single oral (PO) administration:** _(time frame: Day 10)_ — Parameter: CL/F
- **PK profile (Vz/F) of HRS-5041 after a single oral (PO) administration:** _(time frame: Day 10)_ — Parameter: Vz/F

## Secondary Outcomes

- **Safety and tolerability - number and severity of adverse events** _(time frame: Day 10)_
- **Safety and tolerability - Blood pressure** _(time frame: Day 10)_
- **Safety and tolerability - Body temperature** _(time frame: Day 10)_
- **Safety and tolerability - Physical examination** _(time frame: Day 10)_
- **Safety and tolerability - Laboratory tests** _(time frame: Day 10)_
- **Safety and tolerability - ECG** _(time frame: Day 10)_

## Locations (1)

- Nucleus Network Melbourne, Melbourne, Victoria, Australia

## 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.nucleus network melbourne|melbourne|victoria|australia` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT06559007.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06559007*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*