Share
Save
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.
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
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
Find a site
Closest Location:
Nucleus Network Melbourne
Research sites nearby
Select from list below to view details:
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
| DRUG: HRS-5041 dose level 1
|
EXPERIMENTAL: Experimental: HRS-5041 dose level 2
| DRUG: HRS-5041 dose level 2
|
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
Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol
No questions submitted. Be the first to ask a question!