Phase 1 Study to Evaluate PK, Safety, and Tolerability of HRS-5041 in Healthy Caucasian Male Participants

Phase 1

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: HRS-5041 dose level 1; Drug: HRS-5041 dose level 2

• Registration Number: NCT06559007
• Lead Sponsor: Atridia Pty Ltd.

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.

Study Timeline

• Study First Submitted: 2024-08-02
• Study First Submitted QC: 2024-08-14
• Study First Posted: 2024-08-19
• Status Verified: 2024-09
• Study Start: 2024-09-25
• Primary Completion: 2025-01-06
• Study Completion: 2025-03-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental: HRS-5041 dose level 1	HRS-5041 dose level 1	Sing dose level 1
Experimental: HRS-5041 dose level 2	HRS-5041 dose level 2	Sing dose level 2

Primary Outcome Measures

Name	Time	Method
PK profile (AUC0-t) of HRS-5041 after a single oral (PO) administration:	Day 10	Parameter: AUC0-t
PK profile (Cmax) of HRS-5041 after a single oral (PO) administration:	Day 10	Parameters: Cmax
PK profile (AUC0-inf) of HRS-5041 after a single oral (PO) administration:	Day 10	Parameter:AUC0-inf
PK profile (CL/F) of HRS-5041 after a single oral (PO) administration:	Day 10	Parameter: CL/F
PK profile (Tmax) of HRS-5041 after a single oral (PO) administration:	Day 10	Parameter: Tmax
PK profile ( t1/2) of HRS-5041 after a single oral (PO) administration:	Day 10	Parameter: t1/2
PK profile (Vz/F) of HRS-5041 after a single oral (PO) administration:	Day 10	Parameter: Vz/F

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability - Laboratory tests	Day 10	Number of abnormalities assessed based on safety bloods and urine test
Safety and tolerability - number and severity of adverse events	Day 10	Incidence and severity of AE
Safety and tolerability - Blood pressure	Day 10	Incidence of Adverse Events and Abnormalities as assessed by blood pressure (systolic and diastolic pressure)
Safety and tolerability - Body temperature	Day 10	Incidence of Adverse Events and Abnormalities as assessed by body temperature
Safety and tolerability - ECG	Day 10	heart rate, PR interval, QT interval, corrected QT (QTcF using Fridericia's formula) interval, and QRS
Safety and tolerability - Physical examination	Day 10	Incidence of Adverse Events and Abnormalities as Assessed by Physical Examination

Trial Locations

Locations (1)

Nucleus Network Melbourne; 🇦🇺 Melbourne, Victoria, Australia