A Study of RAY1225 in Participants With Impaired Liver Function

Guangdong Raynovent Biotech

Status and phase: Enrolling; Phase 1

Conditions: Hepatic Impairment

Treatments: Drug: RAY1225

Study type: Interventional

Funder types: Industry

Identifiers

NCT06577415

RAY1225-24-04

Details and patient eligibility

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

24 participants in 3 patient groups

Mild Hepatic Impairment

Experimental group

Description:

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

Treatment:

Drug: RAY1225

Moderate Hepatic Impairment

Experimental group

Description:

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

Treatment:

Drug: RAY1225

Normal Hepatic Function

Active Comparator group

Description:

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

Treatment:

Drug: RAY1225