The Affiliated hospital of QingDao University
Qingdao, Shandong, 266000, China
NCT Number: NCT05505955
The trial is the first human trial. The safety, tolerability, PK and PD of HRS-5965 tablets will be evaluated in healthy subjects and subjects with impaired renal function. The study was divided into three parts:
Part 1: single ascending dose, randomized, double-blind study,with 6 dose groups preset, of which 1 group will be administered under fasted and fed conditions; Part 2: Multiple ascending dose, randomized, double-blind study,with 4 dose groups preset; Part 3: an open-label, nonrandomized, single-dose study to evaluate the effect of severe renal impairment (RI) on the safety, tolerability, pharmacokinetics, and pharmacodynamics of HRS -5965 compared to demographically-matched healthy participants with normal renal function.
Looking for future studies?
Notify Me18 year–70 year
All sexes
Interventional
Phase 1
Qingdao, Shandong, 266000, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Study on subjects with renal insufficiency
Exclusion criteria
Study on subjects with renal insufficiency
Subjects took HRS5965 tablets in Part 1, Part 2 and Part 3.
Subjects took Placebo in Part 1 and Part 2.
Time frame: up to 24 days
Time frame: Pre-dose to 144 hours post-dose
Time frame: Pre-dose to 144 hours post-dose
Time frame: Pre-dose to 144 hours post-dose
Time frame: Pre-dose to 144 hours post-dose
Time frame: Pre-dose to 144 hours post-dose
Time frame: Pre-dose to 144 hours post-dose
Chengdu Suncadia Medicine Co., Ltd.
Industry
A Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetics/Pharmacodynamics of Single and Multiple Dose of HRS-5965 Tablets in Healthy Subjects, and the Food Effect on Pharmacokinetics, and Pharmacokinetics in Subjects With Impaired Renal Function
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.
NCT05434325
Autoimmune Diseases, Chronic Disease
Concord W., New South Wales, Australia
View Trial DetailsNCT05174221
Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications
Northridge, California, United States
View Trial DetailsNCT06835322
Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications
Alexandria, Egypt
View Trial DetailsNCT04733040
Autoimmune Diseases, Female Urogenital Diseases
Tbilisi, Georgia
View Trial Details