Status:
COMPLETED
Phase 1 Study to Evaluate PK, Safety, and Tolerability of HRS-5041 in Healthy Caucasian Male Participants
Lead Sponsor:
Atridia Pty Ltd.
Conditions:
Prostate Cancer
Eligibility:
MALE
18-55 years
Phase:
PHASE1
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 partic...
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 Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 3 2025
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06559007
Start Date
September 25 2024
End Date
March 3 2025
Last Update
March 18 2025
Active Locations (1)
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1
Nucleus Network Melbourne
Melbourne, Victoria, Australia, 3004