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
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
Treatments tested in this trial
- RAY1225
Treatment groups
24 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov