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

NCT07625618 | Completed Phase 1

• 1 other identifier: MY008211-1-09
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatic Insufficiency (MeSH ID: D048550)

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (10)

• Tmax

  up to 12 weeks

• CL/F

  up to 12 weeks

• Vz/F

  up to 12 weeks

• t1/2

  up to 12 weeks

• body temperature

  up to 12 weeks

Study Arms (3)

normal hepatic function group

EXPERIMENTAL

Each subject will take a single oral dose of 400 mg MY008211A Tablets under fasting conditions.

Drug: MY008211A tablets

mild hepatic impairment (Child-Pugh A) group

EXPERIMENTAL

Each subject will take a single oral dose of 400 mg MY008211A Tablets under fasting conditions.

Drug: MY008211A tablets

moderate hepatic impairment (Child-Pugh B) group

EXPERIMENTAL

Drug: MY008211A tablets

Interventions

MY008211A tablets DRUG

Each subject will take a single oral dose of 400 mg MY008211A Tablets under fasting conditions.

mild hepatic impairment (Child-Pugh A) group; moderate hepatic impairment (Child-Pugh B) group; normal hepatic function group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Wuhan Createrna Science and Technology Co., Ltd: lead

Study Sites (1)

The First Hospital of Jilin University

Jilin City, Changchun, 130000, China

Location

MeSH Terms

Conditions

Hepatic Insufficiency

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Officials

• YaNan Wang, PHD

  The First Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2026
• First Posted: June 4, 2026
• Study Start: September 20, 2024
• Primary Completion: December 28, 2024
• Study Completion: December 28, 2024
• Last Updated: June 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)