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

PHASE1RECRUITING

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.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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
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    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : Yes

    Gender eligible for study: Male

    Things to know

    Study dates

    Study start: 2024-09-25

    Primary completion: 2024-12-03

    Study completion finish: 2024-12-15

    study type

    Study type

    TREATMENT

    phase

    Phase

      PHASE1

    trial

    Trial ID

    NCT06559007

    Intervention or treatment

    DRUG: HRS-5041 dose level 1

    DRUG: HRS-5041 dose level 2

    Conditions

    • Prostate Cancer

    Find a site

    Closest Location:

    Nucleus Network Melbourne

    Research sites nearby

    Select from list below to view details:

    • Nucleus Network Melbourne

      Melbourne, Victoria, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/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
    EXPERIMENTAL: Experimental: HRS-5041 dose level 2
    • Sing dose level 2
    DRUG: HRS-5041 dose level 2
    • Single dose of HRS-5041 orally administered

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    PK profile (Cmax) of HRS-5041 after a single oral (PO) administration:Parameters: CmaxDay 10
    PK profile (AUC0-t) of HRS-5041 after a single oral (PO) administration:Parameter: AUC0-tDay 10
    PK profile (AUC0-inf) of HRS-5041 after a single oral (PO) administration:Parameter:AUC0-infDay 10
    PK profile (Tmax) of HRS-5041 after a single oral (PO) administration:Parameter: TmaxDay 10
    PK profile ( t1/2) of HRS-5041 after a single oral (PO) administration:Parameter: t1/2Day 10
    PK profile (CL/F) of HRS-5041 after a single oral (PO) administration:Parameter: CL/FDay 10
    PK profile (Vz/F) of HRS-5041 after a single oral (PO) administration:Parameter: Vz/FDay 10

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Safety and tolerability - number and severity of adverse eventsIncidence and severity of AEDay 10
    Safety and tolerability - Blood pressureIncidence of Adverse Events and Abnormalities as assessed by blood pressure (systolic and diastolic pressure)Day 10
    Safety and tolerability - Body temperatureIncidence of Adverse Events and Abnormalities as assessed by body temperatureDay 10
    Safety and tolerability - Physical examinationIncidence of Adverse Events and Abnormalities as Assessed by Physical ExaminationDay 10
    Safety and tolerability - Laboratory testsNumber of abnormalities assessed based on safety bloods and urine testDay 10
    Safety and tolerability - ECGheart rate, PR interval, QT interval, corrected QT (QTcF using Fridericia's formula) interval, and QRSDay 10

    Frequently Asked Questions

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    References

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

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