NCT06559007CompletedPhase 1
Phase 1 Study to Evaluate PK, Safety, and Tolerability of HRS-5041 in Healthy Caucasian Male Participants
A Phase 1, Open-Label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Single Dose HRS-5041 in Healthy Caucasian Male Participants
Source: ClinicalTrials.gov · Last updated 18 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- First submitted
- 2 Aug 2024
- Start date
- 25 Sept 2024
- Primary completion date
- 6 Jan 2025
- Lead sponsor
- Atridia Pty Ltd.
- Diseases
- Prostate cancer
- NCT number
- NCT06559007
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 24
- From 25 Sept 2024 to the primary completion date, 6 Jan 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of receiving any androgen receptor (AR) degraders.
Other illness
- History of severe abnormal gastric emptying, severe gastrointestinal (GI) disease, or participants who had GI surgeries (except GI polypectomy).
- Severe infections, injuries, or major surgeries as determined by the investigator within 6 months
Lab values
- 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.
Other
- History or evidence of clinically significant
Who the study is looking for
- Healthy Caucasian participants;
- Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial,
- Male aged between 18 to 55 years of age (inclusive) at the date of signed consent form.
- Total body weight ≥ 50.0 kg, body mass index (BMI) between 19.0 and 32.0 kg/m2 (inclusive) at screening.
Age in the registry: 18 years to 55 years · Sex: Male · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nucleus Network Melbourne Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.