A Pharmacokinetic and Safety Study of MY008211A Tablets in Subjects With Impaired or Normal Hepatic Function

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.

Study Overview

• Status: Completed
• Conditions: Hepatic Insufficiency (MeSH ID: D048550)
• Intervention / Treatment: Drug: MY008211A tablets

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Changchun
    • Jilin, Changchun, China, 130000
      • The First Hospital of Jilin University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Voluntarily participate in the clinical study and sign the written ICF, be able to understand the procedures and methods of this study, and be able to complete the entire study process according to the study requirements;
• Age 18 to 70 years (inclusive) on the day of signing the ICF, male or female;
• Body weight: ≥ 50 kg for males, ≥ 45 kg for females; body mass index (BMI): 18.0-32.0 kg/m2 (both inclusive);
• Subjects (including their partners) have no birth plan from screening until 3 months after the administration of the investigational product and voluntarily take contraceptive measures, and have no plans to donate sperm or eggs;
• Glomerular filtration rate (calculated using the CKD-EPI formula) ≥ 60 mL/min;

Exclusion Criteria:

• Known or suspected history of immunodeficiency (e.g., history of frequent recurrent infections), hereditary or acquired complement deficiency;
• Clear history of capsular microbial infection within 6 months before screening, including but not limited to Streptococcus pneumoniae, Bacillus anthracis, Salmonella, Salmonella typhi, Klebsiella pneumoniae, Pseudomonas aeruginosa, Bacteroides fragilis, Neisseria meningitidis, Haemophilus influenzae and Legionella pneumophila.
• Subjects who have a previous history of tuberculosis infection or are currently suffering from tuberculosis infection;
• Active systemic bacterial, viral or fungal infections within 14 days before administration;
• Fever (≥ 38°C) within 7 days before administration;
• Subjects suspected of having a history of allergy to any component of the investigational product, or with allergic constitution (allergic to multiple drugs and foods, and judged by the investigator to be clinically significant);
• Those who have previously undergone surgery that, as judged by the investigator, will affect drug absorption, distribution, metabolism and excretion; or those who have undergone surgery within 4 weeks prior to screening; or those who plan to undergo surgery during the study;
• Those who cannot tolerate venipuncture or with a history of blood phobia and acupuncture syncope;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: normal hepatic function group; 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.
Experimental: mild hepatic impairment (Child-Pugh A) group; 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.
Experimental: moderate hepatic impairment (Child-Pugh B) group	Drug: MY008211A tablets; Each subject will take a single oral dose of 400 mg MY008211A Tablets under fasting conditions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	maximum concentration	up to 12 weeks
AUC0-last	area under the plasma concentration-time curve from 0 to the last quantifiable time point	up to 12 weeks
AUC0-inf	area under the plasma concentration-time curve from 0 to infinity	up to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tmax	time to reach maximum concentration	up to 12 weeks
CL/F	apparent clearance	up to 12 weeks
Vz/F	apparent volume of distribution	up to 12 weeks
t1/2	terminal half-life	up to 12 weeks
body temperature	Measure the body temperature of the subjects, using degrees Celsius as the unit.	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.	up to 12 weeks
12-lead ECG	Evaluate QT interval, PR interval, etc.	up to 12 weeks
adverse events and serious adverse events		up to 12 weeks
Pulse	Measure the pulse of the subjects, expressing it in units of beats per minute.	up to 12 weeks
Blood pressure	Measure the systolic and diastolic blood pressure of the subjects, with the unit of mm/hg.	up to 12 weeks

Collaborators and Investigators

• Sponsor: Wuhan Createrna Science and Technology Co., Ltd
• Investigators: Principal Investigator: YaNan Wang, PHD, The First Hospital of Jilin University

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2024
• Primary Completion (Actual): December 28, 2024
• Study Completion (Actual): December 28, 2024

Study Registration Dates

• First Submitted: May 9, 2026
• First Submitted That Met QC Criteria: May 28, 2026
• First Posted (Actual): June 4, 2026

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Hepatic Insufficiency
• Other Study ID Numbers: MY008211-1-09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The company's business decision

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No