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A Study of RAY1225 in Participants With Impaired Liver Function

ConditionHepatic Impairment
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGuangdong Raynovent Biotech Co., Ltd

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • RAY1225

    Drug

    Administered SC

Treatment groups

24 Participants
are divided into 3 treatment groups
Group A: Mild Hepatic ImpairmentExperimental treatment 1 intervention
Group B: Moderate Hepatic ImpairmentExperimental treatment 1 intervention
Group C: Normal Hepatic FunctionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
DAY1~43
2

PK: Maximum Observed Drug Concentration (Cmax) of RAY1225

PK: Maximum Observed Drug Concentration (Cmax) of RAY1225

Time frame
DAY1~43

Secondary outcomes

1

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

Time frame
DAY1~43

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guangdong Raynovent Biotech Co., Ltd

Lead sponsor

Source ClinicalTrials.gov
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