Prostate CancerPhase 1NCT06559007
Phase 1 Study to Evaluate PK, Safety, and Tolerability of HRS-5041 in Healthy Caucasian Male Participants
A Phase 1 study testing HRS-5041 dose level 1 and HRS-5041 dose level 2 in people with Prostate Cancer, run by Atridia Pty Ltd. at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- HRS-5041 dose level 1 and HRS-5041 dose level 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteAustralia
- Study dates
- 25 Sep 2024to 3 Mar 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- History of receiving any androgen receptor (AR) degraders.
- History or evidence of clinically significant
- 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
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- HRS-5041 dose level 1, HRS-5041 dose level 2
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-5041 dose level 1Drug
Also called HRS-5041 (single dose, oral administration, dose level 1)
Single dose of HRS-5041 orally administered
HRS-5041 dose level 2Drug
Also called HRS-5041 (single dose, oral administration, dose level 2)
Single dose of HRS-5041 orally administered
| Study group | Role | What they receive |
|---|---|---|
| Experimental: HRS-5041 dose level 1 | Experimental | Sing dose level 1 Receives: Drug: HRS-5041 dose level 1 |
| Experimental: HRS-5041 dose level 2 | Experimental | Sing dose level 2 Receives: Drug: HRS-5041 dose level 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK profile (Cmax) of HRS-5041 after a single oral (PO) administration:
Parameters: Cmax
Measured: Day 10
PK profile (AUC0-t) of HRS-5041 after a single oral (PO) administration:
Parameter: AUC0-t
Measured: Day 10
PK profile (AUC0-inf) of HRS-5041 after a single oral (PO) administration:
Parameter:AUC0-inf
Measured: Day 10
PK profile (Tmax) of HRS-5041 after a single oral (PO) administration:
Parameter: Tmax
Measured: Day 10
PK profile ( t1/2) of HRS-5041 after a single oral (PO) administration:
Parameter: t1/2
Measured: Day 10
PK profile (CL/F) of HRS-5041 after a single oral (PO) administration:
Parameter: CL/F
Measured: Day 10
PK profile (Vz/F) of HRS-5041 after a single oral (PO) administration:
Parameter: Vz/F
Measured: Day 10
Secondary outcomes (6)
Safety and tolerability - number and severity of adverse events
Incidence and severity of AE
Measured: Day 10
Safety and tolerability - Blood pressure
Incidence of Adverse Events and Abnormalities as assessed by blood pressure (systolic and diastolic pressure)
Measured: Day 10
Safety and tolerability - Body temperature
Incidence of Adverse Events and Abnormalities as assessed by body temperature
Measured: Day 10
Safety and tolerability - Physical examination
Incidence of Adverse Events and Abnormalities as Assessed by Physical Examination
Measured: Day 10
Safety and tolerability - Laboratory tests
Number of abnormalities assessed based on safety bloods and urine test
Measured: Day 10
Safety and tolerability - ECG
heart rate, PR interval, QT interval, corrected QT (QTcF using Fridericia's formula) interval, and QRS
Measured: Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start25 Sep 2024
- Primary completion6 Jan 2025
- Study completion3 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atridia Pty Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06559007
- Sponsor's protocol ID
- HRS-5041-102
- Status last verified
- Sep 2024
- First submitted
- 2 Aug 2024
- Last updated
- 18 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06559007
- Acronym / sponsor ID
- HRS-5041-102
- Conditions
- Prostate Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Atridia Pty Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Sep 2024 (actual)
- Primary completion
- 6 Jan 2025 (actual)
- Study completion
- 3 Mar 2025 (actual)
- First posted
- 19 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: HRS-5041 dose level 1 | Experimental | Drug: HRS-5041 dose level 1Sing dose level 1 |
| Experimental: HRS-5041 dose level 2 | Experimental | Drug: HRS-5041 dose level 2Sing dose level 2 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- History of receiving any androgen receptor (AR) degraders.
- History or evidence of clinically significant
- 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
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRS-5041 dose level 1Also: HRS-5041 (single dose, oral administration, dose level 1)Single dose of HRS-5041 orally administered | Drug | Experimental: HRS-5041 dose level 1 |
| HRS-5041 dose level 2Also: HRS-5041 (single dose, oral administration, dose level 2)Single dose of HRS-5041 orally administered | Drug | Experimental: HRS-5041 dose level 2 |
Primary outcome
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
6 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HRS-5041 dose level 1 and HRS-5041 dose level 2 in people with Prostate Cancer, run by Atridia Pty Ltd. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PK profile (Cmax) of HRS-5041 after a single oral (PO) administration: (time frame: Day 10). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.