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NCT Number: NCT06577415

A Study of RAY1225 in Participants With Impaired Liver Function

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.

Recruiting

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Nanfang Hospital,South Medical Hospital

Guangzhou, Guangdong, China

Location status: Recruiting

Location contact

Zhongyuan XU

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

RAY1225

Drug

Administered SC

Primary outcomes

  1. Pharmacokinetics (PK): Area Under The Drug Concentration-Time Curve From Zero To Infinity (AUC[0-∞]) of RAY1225

    Time frame: DAY1~43

    Pharmacokinetics (PK): Area Under The Drug Concentration-Time Curve From Zero To Infinity (AUC[0-∞]) of RAY1225.

  2. PK: Maximum Observed Drug Concentration (Cmax) of RAY1225

    Time frame: DAY1~43

    PK: Maximum Observed Drug Concentration (Cmax) of RAY1225

Secondary outcomes

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

    Time frame: DAY1~43

Study contacts

Contact information is provided by the study sponsor or research team.

Zhongyuan XU

CONTACT

[email protected]

020-62786845

Sponsors and collaborators

Lead sponsor

Guangdong Raynovent Biotech Co., Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 29, 2024
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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