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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06559007




Registration number
NCT06559007
Ethics application status
Date submitted
2/08/2024
Date registered
19/08/2024
Date last updated
16/10/2024

Titles & IDs
Public title
Phase 1 Study to Evaluate PK, Safety, and Tolerability of HRS-5041 in Healthy Caucasian Male Participants
Scientific title
A Phase 1, Open-Label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Single Dose HRS-5041 in Healthy Caucasian Male Participants
Secondary ID [1] 0 0
HRS-5041-102
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - HRS-5041 dose level 1
Treatment: Drugs - HRS-5041 dose level 2

Experimental: Experimental: HRS-5041 dose level 1 - Sing dose level 1

Experimental: Experimental: HRS-5041 dose level 2 - Sing dose level 2


Treatment: Drugs: HRS-5041 dose level 1
Single dose of HRS-5041 orally administered

Treatment: Drugs: HRS-5041 dose level 2
Single dose of HRS-5041 orally administered
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
PK profile (Cmax) of HRS-5041 after a single oral (PO) administration:
Timepoint [1] 0 0
Day 10
Primary outcome [2] 0 0
PK profile (AUC0-t) of HRS-5041 after a single oral (PO) administration:
Timepoint [2] 0 0
Day 10
Primary outcome [3] 0 0
PK profile (AUC0-inf) of HRS-5041 after a single oral (PO) administration:
Timepoint [3] 0 0
Day 10
Primary outcome [4] 0 0
PK profile (Tmax) of HRS-5041 after a single oral (PO) administration:
Timepoint [4] 0 0
Day 10
Primary outcome [5] 0 0
PK profile ( t1/2) of HRS-5041 after a single oral (PO) administration:
Timepoint [5] 0 0
Day 10
Primary outcome [6] 0 0
PK profile (CL/F) of HRS-5041 after a single oral (PO) administration:
Timepoint [6] 0 0
Day 10
Primary outcome [7] 0 0
PK profile (Vz/F) of HRS-5041 after a single oral (PO) administration:
Timepoint [7] 0 0
Day 10
Secondary outcome [1] 0 0
Safety and tolerability - number and severity of adverse events
Timepoint [1] 0 0
Day 10
Secondary outcome [2] 0 0
Safety and tolerability - Blood pressure
Timepoint [2] 0 0
Day 10
Secondary outcome [3] 0 0
Safety and tolerability - Body temperature
Timepoint [3] 0 0
Day 10
Secondary outcome [4] 0 0
Safety and tolerability - Physical examination
Timepoint [4] 0 0
Day 10
Secondary outcome [5] 0 0
Safety and tolerability - Laboratory tests
Timepoint [5] 0 0
Day 10
Secondary outcome [6] 0 0
Safety and tolerability - ECG
Timepoint [6] 0 0
Day 10

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/09/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/12/2024
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network Melbourne - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Atridia Pty Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT06559007
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Kathy You
Address 0 0
Country 0 0
Phone 0 0
+61 02 9299 0433
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06559007