Nucleus Network Melbourne
Melbourne, Victoria, 3004, Australia
NCT Number: NCT06559007
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.
Looking for future studies?
Notify Me18 year–55 year
Male
Interventional
Phase 1
Melbourne, Victoria, 3004, Australia
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Single dose of HRS-5041 orally administered
Other names: HRS-5041 (single dose, oral administration, dose level 1)
Single dose of HRS-5041 orally administered
Other names: HRS-5041 (single dose, oral administration, dose level 2)
Time frame: Day 10
Parameters: Cmax
Time frame: Day 10
Parameter: AUC0-t
Time frame: Day 10
Parameter:AUC0-inf
Time frame: Day 10
Parameter: Tmax
Time frame: Day 10
Parameter: t1/2
Time frame: Day 10
Parameter: CL/F
Time frame: Day 10
Parameter: Vz/F
Time frame: Day 10
Incidence and severity of AE
Time frame: Day 10
Incidence of Adverse Events and Abnormalities as assessed by blood pressure (systolic and diastolic pressure)
Time frame: Day 10
Incidence of Adverse Events and Abnormalities as assessed by body temperature
Time frame: Day 10
Incidence of Adverse Events and Abnormalities as Assessed by Physical Examination
Time frame: Day 10
Number of abnormalities assessed based on safety bloods and urine test
Time frame: Day 10
heart rate, PR interval, QT interval, corrected QT (QTcF using Fridericia's formula) interval, and QRS
Atridia Pty Ltd.
Industry
A Phase 1, Open-Label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Single Dose HRS-5041 in Healthy Caucasian Male Participants
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.
NCT03269422
Genital Diseases, Genital Diseases, Male
Basking Ridge, New Jersey, United States
View Trial DetailsNCT05754658
Breast Cancer, Breast Diseases
Philadelphia, Pennsylvania, United States
View Trial DetailsNCT03606837
Genital Diseases, Genital Diseases, Male
Bordeaux, France
View Trial DetailsNCT06540794
Genital Diseases, Genital Diseases, Male
Istanbul, Turkey (Türkiye)
View Trial Details