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

NCT ID: NCT06559007

Last Updated: 2025-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-25
• Study Completion Date: 2025-03-03

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental: HRS-5041 dose level 1

Sing dose level 1

Group Type: EXPERIMENTAL

HRS-5041 dose level 1

Intervention Type: DRUG

Single dose of HRS-5041 orally administered

Experimental: HRS-5041 dose level 2

Sing dose level 2

Group Type: EXPERIMENTAL

HRS-5041 dose level 2

Intervention Type: DRUG

Single dose of HRS-5041 orally administered

Interventions

HRS-5041 dose level 1

Single dose of HRS-5041 orally administered

Intervention Type: DRUG

HRS-5041 dose level 2

Single dose of HRS-5041 orally administered

Intervention Type: DRUG

Other Intervention Names

HRS-5041 (single dose, oral administration, dose level 1); HRS-5041 (single dose, oral administration, dose level 2)

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Atridia Pty Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nucleus Network Melbourne

Melbourne, Victoria, Australia

Countries

Australia

Other Identifiers

HRS-5041-102

Identifier Type: -

Identifier Source: org_study_id