Actively Recruiting

Phase 1
Age: 18Years - 75Years
All Genders
Healthy Volunteers
NCT06577415

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

Age: 18Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Nanfang Hospital,South Medical Hospital

Guangzhou, Guangdong, China

Actively Recruiting

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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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