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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: HRS-5041 dose level 1; Drug: HRS-5041 dose level 2

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • Nucleus Network Melbourne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: HRS-5041 dose level 1; Sing dose level 1	Drug: HRS-5041 dose level 1; Single dose of HRS-5041 orally administered; Other Names: HRS-5041 (single dose, oral administration, dose level 1)
Experimental: Experimental: HRS-5041 dose level 2; Sing dose level 2	Drug: HRS-5041 dose level 2; Single dose of HRS-5041 orally administered; Other Names: HRS-5041 (single dose, oral administration, dose level 2)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Atridia Pty Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2024
• Primary Completion (Actual): January 6, 2025
• Study Completion (Actual): March 3, 2025

Study Registration Dates

• First Submitted: August 2, 2024
• First Submitted That Met QC Criteria: August 14, 2024
• First Posted (Actual): August 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 17, 2025
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: HRS-5041-102

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No