GS1-144 in Participants With Hepatic Impairment and Healthy Female
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorChangchun GeneScience Pharmaceutical Co., Ltd.
About this trial
GS1-144 in Participants with Hepatic Impairment and Healthy Female
Eligibility criteria
Qualifiers
Participants who sign the ICF prior to the trial, have a full understanding of the trial content, procedures, and possible adverse reactions, and are able to complete the study in accordance with the protocol requirements。
Female participants aged 18-70 years (inclusive) (age-matched between the normal hepatic function group and the hepatic impairment groups, mean ±10 years).
Females of childbearing potential who are willing to use adequate and effective contraception from the date of signing the ICF until 1 month after administration of the investigational drug.
Body weight ≥ 45.0 kg (body weight matched between the normal hepatic function group and the hepatic impairment groups, mean body weight ±10 kg), with BMI within 18.0-32.0 kg/m2 (inclusive).
Disqualifiers
Allergic constitution (e.g., allergy to more than two drugs or foods), or a history of allergy to the investigational drug or any excipients thereof.
Use of tobacco-containing products, nicotine, or nicotine-containing products (e.g., e-cigarettes) within 1 month prior to screening, or unwillingness to stop smoking during the study.
Alcohol abuse within 3 months prior to screening (weekly consumption ≥ 14 units of alcohol: 1 unit = 360 mL of beer, or 45 mL of spirits with an alcohol content of 40%, or 150 mL of wine), or unwillingness to stop drinking during the study.
Blood loss or donation of ≥ 450 mL of whole blood or plasma within 3 months prior to screening, or receipt of any transfusion of blood or blood products within 60 days.
Trial design
Treatments tested in this trial
- GS1-144 tablet
Treatment groups
24 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov