NCT06559007

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 prostate-cancer

Timeline
Completed

Started Sep 2024

Shorter than P25 for phase_1 prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 19, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

September 25, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2025

Completed
Last Updated

March 18, 2025

Status Verified

September 1, 2024

Enrollment Period

3 months

First QC Date

August 2, 2024

Last Update Submit

March 17, 2025

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (7)

  • 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 Outcomes (6)

  • Safety and tolerability - number and severity of adverse events

    Day 10

  • Safety and tolerability - Blood pressure

    Day 10

  • Safety and tolerability - Body temperature

    Day 10

  • Safety and tolerability - Physical examination

    Day 10

  • Safety and tolerability - Laboratory tests

    Day 10

  • +1 more secondary outcomes

Study Arms (2)

Experimental: HRS-5041 dose level 1

EXPERIMENTAL

Sing dose level 1

Drug: HRS-5041 dose level 1

Experimental: HRS-5041 dose level 2

EXPERIMENTAL

Sing dose level 2

Drug: HRS-5041 dose level 2

Interventions

HRS-5041 dose level 1DRUG

Single dose of HRS-5041 orally administered

Also known as: HRS-5041 (single dose, oral administration, dose level 1)
Experimental: HRS-5041 dose level 1
HRS-5041 dose level 2DRUG

Single dose of HRS-5041 orally administered

Also known as: HRS-5041 (single dose, oral administration, dose level 2)
Experimental: HRS-5041 dose level 2

Eligibility Criteria

Age18 Years - 55 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nucleus Network Melbourne

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Administration, Oral

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeutics

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2024

First Posted

August 19, 2024

Study Start

September 25, 2024

Primary Completion

January 6, 2025

Study Completion

March 3, 2025

Last Updated

March 18, 2025

Record last verified: 2024-09

Locations

AU(1)