Actively Recruiting
Study of a Single Subcutaneous Dose of RAY1225 in Adults With Normal or Mild to Moderate Liver Dysfunction
Led by Guangdong Raynovent Biotech Co., Ltd · Updated on 2025-03-19
24
Participants Needed
1
Research Sites
2 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how quickly the drug RAY1225 enters and leaves the bloodstream in adults with mild to moderate liver problems compared to those with healthy liver function. This phase 1 trial focuses on understanding the drugs behavior in participants with impaired liver function to gather basic scientific information. Participants are divided into three groups those with mild liver impairment, moderate liver impairment, and normal liver function. Each participant receives a single subcutaneous dose of 3 milligrams of RAY1225. The study measures how the drug is absorbed and processed over a period from day 1 to day 43. Throughout the study, participants undergo various assessments including blood tests to measure drug concentration and monitor for any adverse effects related to the drug. The main outcomes include the area under the drug concentration-time curve and the maximum drug concentration observed. Safety is also tracked by recording any drug-related side effects during the 43-day period. The total participation duration spans approximately six weeks.
CONDITIONS
Brief Title
A Study of RAY1225 in Participants With Impaired Liver Function
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Body mass index (BMI) between 20 and 32 kg/m2
- Use of reliable contraception during the study and for 6 months after the last dose
- Signed informed consent confirming understanding of the trial
- Estimated glomerular filtration rate (eGFR) of 60 mL/min/1.73 m2 or higher
- For normal liver function group: healthy adults with no liver problems based on medical history and tests
- For hepatic impairment group: adults with chronic mild or moderate liver impairment assessed by Child-Pugh scoring
You will not qualify if you...
- Allergic disposition or likely allergy to the study drug or its components
- QTcF interval greater than 450 milliseconds
- Serious infections, trauma, or major surgery within the last 4 weeks
- 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 past 3 months
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
- For normal liver function group: any history or signs of liver impairment
- For hepatic impairment group: serious illnesses other than liver disease that may affect trial results, drug-induced liver injury, liver transplant history, or cirrhosis with serious complications such as liver failure or cancer
Research Team
Z
Zhongyuan XU
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