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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.

Studieoversigt

Status

Afsluttet

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

24

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Changchun
      • Jilin City, Changchun, Kina, 130000
        • The First Hospital of Jilin University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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;

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: normal hepatic function group
Each subject will take a single oral dose of 400 mg MY008211A Tablets under fasting conditions.
Each subject will take a single oral dose of 400 mg MY008211A Tablets under fasting conditions.
Eksperimentel: mild hepatic impairment (Child-Pugh A) group
Each subject will take a single oral dose of 400 mg MY008211A Tablets under fasting conditions.
Each subject will take a single oral dose of 400 mg MY008211A Tablets under fasting conditions.
Eksperimentel: moderate hepatic impairment (Child-Pugh B) group
Each subject will take a single oral dose of 400 mg MY008211A Tablets under fasting conditions.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Cmax
Tidsramme: up to 12 weeks
maximum concentration
up to 12 weeks
AUC0-last
Tidsramme: up to 12 weeks
area under the plasma concentration-time curve from 0 to the last quantifiable time point
up to 12 weeks
AUC0-inf
Tidsramme: up to 12 weeks
area under the plasma concentration-time curve from 0 to infinity
up to 12 weeks

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: YaNan Wang, PHD, The First Hospital of Jilin University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

20. september 2024

Primær færdiggørelse (Faktiske)

28. december 2024

Studieafslutning (Faktiske)

28. december 2024

Datoer for studieregistrering

Først indsendt

9. maj 2026

Først indsendt, der opfyldte QC-kriterier

28. maj 2026

Først opslået (Faktiske)

4. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • MY008211-1-09

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

The company's business decision

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Leverinsufficiens (MeSH ID: D048550)

Kliniske forsøg med MY008211A tablets

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