A Phase 1 interventional study of MY008211A tablets in Hepatic Insufficiency (MeSH ID: D048550), sponsored by Wuhan Createrna Science and Technology Co., Ltd. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-06-04.
Sponsored by Wuhan Createrna Science and Technology Co., Ltd · Phase 1, Interventional, and Prevention
This study is a single-center, non-randomized, open-label, parallel, single-dose study to evaluate the PK profile and safety of MY008211A Tablets in subjects with hepatic impairment.
This study is a single-center, non-randomized, open-label, parallel, single-dose study to evaluate the PK profile and safety of MY008211A Tablets in subjects with hepatic impairment.
It is planned to enroll 24 subjects, male or female. A total of 3 treatment groups will be set up: normal hepatic function group, mild hepatic impairment (Child-Pugh A) group, moderate hepatic impairment (Child-Pugh B) group, with 8 subjects in each group. Each subject will take a single oral dose of 400 mg MY008211A Tablets under fasting conditions.
This study will first enroll subjects in Group A (mild hepatic impairment) and Group B (moderate hepatic impairment). Age, gender and body weight will not be matched between subjects in Groups A and B; after enrollment for Groups A and B is completed, subjects will be enrolled in Group C (normal hepatic function) as control subjects matched with the hepatic impairment subjects (Group A + Group B):
Subjects who sign the informed consent form (ICF) will be screened according to the inclusion/exclusion criteria. Eligible subjects will be admitted to the Clinical Research Unit (CRU) on Day -1 (D-1). On D1, they will take a single oral dose of 400 mg MY008211A Tablets under fasting conditions and will be discharged after completing the observations and drop-out examinations on D4. They will receive a telephone follow-up on D11.
During the study, sample collection, recording of adverse events (AEs), concomitant medication/non-drug therapy, physical examination, vital signs, ECG, and clinical laboratory tests will be performed according to the protocol requirements.
325 studies on the registry are indexed under Hepatic Insufficiency; 53 are open to participants now.
This study's enrollment of 24 is below the median of 36 across 220 interventional studies indexed under Hepatic Insufficiency.
Browse Hepatic Insufficiency studies →Wuhan Createrna Science and Technology Co., Ltd is the lead sponsor of 13 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Each subject will take a single oral dose of 400 mg MY008211A Tablets under fasting conditions.
Drug: MY008211A tablets
Each subject will take a single oral dose of 400 mg MY008211A Tablets under fasting conditions.
Drug: MY008211A tablets
Drug: MY008211A tablets
Each subject will take a single oral dose of 400 mg MY008211A Tablets under fasting conditions.
Cmax
maximum concentration
Time frame: up to 12 weeks
AUC0-last
area under the plasma concentration-time curve from 0 to the last quantifiable time point
Time frame: up to 12 weeks
AUC0-inf
area under the plasma concentration-time curve from 0 to infinity
Time frame: up to 12 weeks
Tmax
time to reach maximum concentration
Time frame: up to 12 weeks
CL/F
apparent clearance
Time frame: up to 12 weeks
Vz/F
apparent volume of distribution
Time frame: up to 12 weeks
t1/2
terminal half-life
Time frame: up to 12 weeks
body temperature
Measure the body temperature of the subjects, using degrees Celsius as the unit.
Time frame: up to 12 weeks
IU/L or mIU/mL of HCG in the blood of reproductive-aged women
The blood human chorionic gonadotropin (HCG) pregnancy test will measure the concentration of HCG in the blood of reproductive-aged women to determine if they are pregnant. The units in the report will be presented in IU/L (international units per liter) and/or mIU/mL.
Time frame: up to 12 weeks
12-lead ECG
Evaluate QT interval, PR interval, etc.
Time frame: up to 12 weeks
adverse events and serious adverse events
Time frame: up to 12 weeks
Pulse
Measure the pulse of the subjects, expressing it in units of beats per minute.
Time frame: up to 12 weeks
Blood pressure
Measure the systolic and diastolic blood pressure of the subjects, with the unit of mm/hg.
Time frame: up to 12 weeks
Plan to share: No — The company's business decision
No publications or documents are linked to this record.
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Wuhan Createrna Science and Technology Co., Ltd