A Study of RAY1225 in Participants With Impaired Liver Function

NCT ID: NCT06577415

Last Updated: 2025-03-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-26
• Study Completion Date: 2025-11-15

Brief Summary

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

Hepatic Impairment

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Mild Hepatic Impairment

Participants with mild hepatic impairment received single subcutaneous dose of 3 milligrams (mg) RAY1225.

Group Type: EXPERIMENTAL

RAY1225

Intervention Type: DRUG

Administered SC

Moderate Hepatic Impairment

Participants with moderate hepatic impairment received single subcutaneous dose of 3 mg RAY1225.

Group Type: EXPERIMENTAL

RAY1225

Intervention Type: DRUG

Administered SC

Normal Hepatic Function

Participants with normal hepatic function received single subcutaneous dose of 3 mg RAY1225.

Group Type: ACTIVE_COMPARATOR

RAY1225

Intervention Type: DRUG

Administered SC

Interventions

RAY1225

Administered SC

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Participant must be ≥ 18 to ≤ 75 years;

2. BMI ≥ 20 kg/m2 up to ≤ 32 kg/m2;

3. Participants (including partners) must use reliable methods of contraception during the study and until 6 months following the last dose of investigational product;

4. Signature of a dated Informed Consent Form (ICF) indicating that the participates has been informed of all the relevant aspects(including adverse events) of the trial prior to enrollment;

5. eGFR ≥ 60 mL/min/1.73 m2;

Participants with Normal Hepatic Function Only:

6. Healthy males or females as determined by medical history, physical examination, and other screening procedures, with normal liver function;

Participants with hepatic impairment only:

7. Males or females with chronic mild and moderate liver impairment, assessed by Child-Pugh scoring.

Exclusion Criteria

1. Participants with an allergic disposition (multiple drug and food allergies) or who, as determined by the investigator, are likely to be allergic to the investigational drug product or any component of the investigational drug product;

2. QTcF> 450ms;

3. Participants with serious infections, trauma, gastrointestinal surgery or other major surgical procedures within 4 weeks;

4. Participates who donated blood or bleeding profusely (> 400 mL) in the 3 months;

5. Pregnant or lactating women, or women of childbearing age with a positive pregnancy test;

6. Smoking averaged more than 10 cigarettes per day in the 3 months prior to screening;

7. Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2;

Participants with Normal Hepatic Function Only:

8. Any history of hepatic impairment, or potential presence of liver function impairment by physical examination and laboratory examination at screening.

Participants with Hepatic Impairment Only:

9. Any history of clinically serious illness or disease or condition except for primary liver disease that the investigator believes may affect the results of the trial, including but not limited to a history of circulatory, endocrine, nervous, digestive, urinary, respiratory or hematological, immune, psychiatric, and metabolic disorders.

10. Participants with drug-induced liver injury; history of liver transplantation; cirrhosis in combination with the following complications: including but not limited to liver failure, hepatic encephalopathy, hepatocellular carcinoma, esophageal bleeding from ruptured fundic varices.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Guangdong Raynovent Biotech Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nanfang Hospital,South Medical Hospital

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhongyuan XU

Role: CONTACT

nfyygcp@126.com

020-62786845

Facility Contacts

Zhongyuan XU

Role: primary

Other Identifiers

RAY1225-24-04

Identifier Type: -

Identifier Source: org_study_id