Actively Recruiting
A Study of RAY1225 in Participants With Impaired Liver Function
Led by Guangdong Raynovent Biotech Co., Ltd · Updated on 2025-03-19
24
Participants Needed
1
Research Sites
63 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to assess how fast RAY1225 gets into the blood stream and how long it takes the body to remove it in participants with impaired liver function compared to healthy participants.
CONDITIONS
Official Title
A Study of RAY1225 in Participants With Impaired Liver Function
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must be 18 to 75 years old
- Body mass index (BMI) between 20 and 32 kg/m2
- Use reliable contraception methods during the study and for 6 months after the last dose
- Signed informed consent form before enrollment
- Estimated glomerular filtration rate (eGFR) of 60 mL/min/1.73 m2 or higher
- Healthy individuals with normal liver function for the normal hepatic function group
- Adults with chronic mild or moderate liver impairment assessed by Child-Pugh scoring for the hepatic impairment group
You will not qualify if you...
- Allergy or likely allergy to the investigational drug or its components
- QTcF interval greater than 450 ms
- Serious infections, trauma, gastrointestinal surgery, or major surgery within 4 weeks prior
- Blood donation or heavy bleeding over 400 mL in the past 3 months
- Pregnant or breastfeeding women or women with a positive pregnancy test
- Smoking more than 10 cigarettes per day in the 3 months before screening
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
- History or signs of liver impairment in the normal hepatic function group
- History of serious illnesses affecting trial results other than primary liver disease in the hepatic impairment group
- Drug-induced liver injury, liver transplant history, or severe cirrhosis complications such as liver failure, encephalopathy, liver cancer, or esophageal bleeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Nanfang Hospital,South Medical Hospital
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
Z
Zhongyuan XU
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
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