Skip to main content
OpenTrials
Completed

NCT Number: NCT06559007

Phase 1 Study to Evaluate PK, Safety, and Tolerability of 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Nucleus Network Melbourne

Melbourne, Victoria, 3004, Australia

About this 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

HRS-5041 dose level 1

Drug

Single dose of HRS-5041 orally administered

Other names: HRS-5041 (single dose, oral administration, dose level 1)

HRS-5041 dose level 2

Drug

Single dose of HRS-5041 orally administered

Other names: HRS-5041 (single dose, oral administration, dose level 2)

Primary outcomes

  1. PK profile (Cmax) of HRS-5041 after a single oral (PO) administration:

    Time frame: Day 10

    Parameters: Cmax

  2. PK profile (AUC0-t) of HRS-5041 after a single oral (PO) administration:

    Time frame: Day 10

    Parameter: AUC0-t

  3. PK profile (AUC0-inf) of HRS-5041 after a single oral (PO) administration:

    Time frame: Day 10

    Parameter:AUC0-inf

  4. PK profile (Tmax) of HRS-5041 after a single oral (PO) administration:

    Time frame: Day 10

    Parameter: Tmax

  5. PK profile ( t1/2) of HRS-5041 after a single oral (PO) administration:

    Time frame: Day 10

    Parameter: t1/2

  6. PK profile (CL/F) of HRS-5041 after a single oral (PO) administration:

    Time frame: Day 10

    Parameter: CL/F

  7. PK profile (Vz/F) of HRS-5041 after a single oral (PO) administration:

    Time frame: Day 10

    Parameter: Vz/F

Secondary outcomes

  1. Safety and tolerability - number and severity of adverse events

    Time frame: Day 10

    Incidence and severity of AE

  2. Safety and tolerability - Blood pressure

    Time frame: Day 10

    Incidence of Adverse Events and Abnormalities as assessed by blood pressure (systolic and diastolic pressure)

  3. Safety and tolerability - Body temperature

    Time frame: Day 10

    Incidence of Adverse Events and Abnormalities as assessed by body temperature

  4. Safety and tolerability - Physical examination

    Time frame: Day 10

    Incidence of Adverse Events and Abnormalities as Assessed by Physical Examination

  5. Safety and tolerability - Laboratory tests

    Time frame: Day 10

    Number of abnormalities assessed based on safety bloods and urine test

  6. Safety and tolerability - ECG

    Time frame: Day 10

    heart rate, PR interval, QT interval, corrected QT (QTcF using Fridericia's formula) interval, and QRS

Sponsors and collaborators

Lead sponsor

Atridia Pty Ltd.

Industry

Registry information

Official study title

A Phase 1, Open-Label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Single Dose HRS-5041 in Healthy Caucasian Male Participants

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 19, 2024
Registry last updated
Mar 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.