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

28. mai 2026 oppdatert av: Wuhan Createrna Science and Technology Co., Ltd
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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

24

Fase

  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Wuhan Createrna Science and Technology Co., Ltd

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

20. september 2024

Primær fullføring (Faktiske)

28. desember 2024

Studiet fullført (Faktiske)

28. desember 2024

Datoer for studieregistrering

Først innsendt

9. mai 2026

Først innsendt som oppfylte QC-kriteriene

28. mai 2026

Først lagt ut (Faktiske)

4. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • MY008211-1-09

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

The company's business decision

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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