A Study of RAY1225 in Participants With Impaired Liver Function

A Single Dose Pharmacokinetic Study of ray1225 in Subjects With Varying Degrees of Hepatic Impairment

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.

Study Overview

• Status: Recruiting
• Conditions: Hepatic Impairment
• Intervention / Treatment: Drug: RAY1225

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Zhongyuan XU; Phone Number: 020-62786845; Email: nfyygcp@126.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • Nanfang Hospital,South Medical Hospital
      • Contact: Zhongyuan XU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mild Hepatic Impairment; Participants with mild hepatic impairment received single subcutaneous dose of 3 milligrams (mg) RAY1225.	Drug: RAY1225; Administered SC
Experimental: Moderate Hepatic Impairment; Participants with moderate hepatic impairment received single subcutaneous dose of 3 mg RAY1225.	Drug: RAY1225; Administered SC
Active Comparator: Normal Hepatic Function; Participants with normal hepatic function received single subcutaneous dose of 3 mg RAY1225.	Drug: RAY1225; Administered SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK): Area Under The Drug Concentration-Time Curve From Zero To Infinity (AUC[0-∞]) of RAY1225	Pharmacokinetics (PK): Area Under The Drug Concentration-Time Curve From Zero To Infinity (AUC[0-∞]) of RAY1225.	DAY1~43
PK: Maximum Observed Drug Concentration (Cmax) of RAY1225	PK: Maximum Observed Drug Concentration (Cmax) of RAY1225	DAY1~43

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of participants with drug-related adverse events as assessed by CTCAE v5.0	DAY1~43

Collaborators and Investigators

• Sponsor: Guangdong Raynovent Biotech Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2024
• Primary Completion (Estimated): October 31, 2025
• Study Completion (Estimated): November 15, 2025

Study Registration Dates

• First Submitted: August 27, 2024
• First Submitted That Met QC Criteria: August 27, 2024
• First Posted (Actual): August 29, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 18, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: RAY1225-24-04

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No