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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

TREATMENT

Phase

PHASE1

Trial ID

NCT06559007

Intervention or treatment

DRUG: HRS-5041 dose level 1

DRUG: HRS-5041 dose level 2

Conditions

• Prostate Cancer

Condition: Prostate Cancer
DRUG: HRS-5041 dose level 1 and other drugs
Melbourne, Victoria, Australia
Sponsor: Atridia Pty Ltd.

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Nucleus Network Melbourne

Research sites nearby

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Nucleus Network Melbourne
Melbourne, Victoria, Australia

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/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
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 Measure	Primary Outcome Description	Primary Outcome 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

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome 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

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