A Study of RAY1225 in Participants With Impaired Liver Function

NCT06577415 | Recruiting Phase 1

• 1 other identifier: RAY1225-24-04
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Number of participants with drug-related adverse events as assessed by CTCAE v5.0

  DAY1~43

Study Arms (3)

Mild Hepatic Impairment

EXPERIMENTAL

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

Drug: RAY1225

Moderate Hepatic Impairment

EXPERIMENTAL

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

Drug: RAY1225

Normal Hepatic Function

ACTIVE COMPARATOR

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

Drug: RAY1225

Interventions

RAY1225 DRUG

Administered SC

Mild Hepatic Impairment; Moderate Hepatic Impairment; Normal Hepatic Function

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must be ≥ 18 to ≤ 75 years;
• BMI ≥ 20 kg/m2 up to ≤ 32 kg/m2;
• Participants (including partners) must use reliable methods of contraception during the study and until 6 months following the last dose of investigational product;
• 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;
• eGFR ≥ 60 mL/min/1.73 m2;
• Participants with Normal Hepatic Function Only:
• Healthy males or females as determined by medical history, physical examination, and other screening procedures, with normal liver function;
• Participants with hepatic impairment only:
• Males or females with chronic mild and moderate liver impairment, assessed by Child-Pugh scoring.

You may not qualify if:

• 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;
• QTcF\> 450ms;
• Participants with serious infections, trauma, gastrointestinal surgery or other major surgical procedures within 4 weeks;
• Participates who donated blood or bleeding profusely (\> 400 mL) in the 3 months;
• Pregnant or lactating women, or women of childbearing age with a positive pregnancy test;
• Smoking averaged more than 10 cigarettes per day in the 3 months prior to screening;
• Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2;
• Participants with Normal Hepatic Function Only:
• 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:
• 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.
• 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.

Sponsors & Collaborators

• Guangdong Raynovent Biotech Co., Ltd: lead

Study Sites (1)

Nanfang Hospital,South Medical Hospital

Guangzhou, Guangdong, China

RECRUITING

Central Study Contacts

Zhongyuan XU

CONTACT

020-62786845; nfyygcp@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: August 29, 2024
• Study Start: August 26, 2024
• Primary Completion: October 31, 2025
• Study Completion: November 15, 2025
• Last Updated: March 19, 2025

Record last verified: 2024-08

Locations

CN (1)