En fase I-studie av XH-S004 i friske frivillige
En fase I-studie for å vurdere sikkerhet, tolerabilitet, farmakokinetikk og mateffekter av XH-S004 etter SAD (single Ascending Doses) og MAD (Multiple Ascending Doses) hos friske frivillige
This is a phase I, randomised, double-blind placebo-controlled, 3-part study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of single and multiple oral doses of XH-S004 in healthy volunteers.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
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Beijing Municipality
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Beijing, Beijing Municipality, Kina
- Beijing LuHe Hospital, Capital Medical University
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusive criteria:
- Healthy male and female subjects, 18 to 45 years of age (inclusive) at Screening.
- Male body weight no less than 50 kilogram (Kg), Female body weight no less than 45 Kg, and body mass index (BMI) between 16.0 and 26.0 kg/m2 (both inclusive).
- Medically healthy without no clinically significant abnormalities on the basis of inquiry, vital signs, physical examination, 12-lead electrocardiogram (ECG), laboratory tests (hematology, serum chemistry, coagulation function and urinalysis, etc,) , and chest X-ray, etc,.
- Participants must be able to understand the procedures and methods of this study, and voluntarily take part in this study, and communicate well with investigators, and comply with requirements throughout the study, and sign the informed consent form (ICF).
- Subjects must guarantee and agree to take effective contraceptive methods (example, condom and intrauterine device) other than oral medication from 14 days prior to signing ICF to 30 days after last dose, and have no plan to donate sperm and ovum during the study.
Exclusive criteria:
- Pregnant or lactating woman, or woman with a positive pregnancy test.
- Participants who are suspected or confirmed to be allergic to any ingredients of investigational product, or participants who are allergic, or have a drug allergy history or specific allergic disorders (asthma, urticaria, eczema, etc.).
- Participants with a medical history or a presence of significant cardiovascular, pulmonary, endocrine, urinary/reproductive, gastrointestinal, dermatologic, immunologic, hematological, neurological, psychiatric and infectious diseases or abnormalities; Or any acute, chronic disease or physiological condition that could interfere with the study results.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: XH-S004 tablet
Participants will receive XH-S004 as per assigned treatment regimen on scheduled days. Part 1 (single ascending dose, 8 cohorts, starting at 5 mg), Part 2 (multiple ascending dose, 3 cohorts), and Part 3 (food effect, 1 cohort), all administered as XH-S004 oral tablets |
XH-S004 tablets will be administered orally as per assigned treatment regimen on schedualed days
Andre navn:
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Placebo komparator: XH-S004 placebo tablet
Participants will receive matching placebo as per assigned treatment regimen on scheduled days. Part 1 (single ascending dose, 8 cohorts) and Part 2 (multiple ascending dose, 3 cohorts) , all administered as matching placebo to XH-S004. |
Matching placebo tablets will be administered orally as per assigned treatment regimen on schedualed days |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
To access the safety and tolerability of single ascending oral dose of XH-S004 in healthy adults.
Tidsramme: Approximately 1~2 weeks.
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The incidence and severity of adverse events (AEs) , serious AEs and abnormalities on laboratory tests. |
Approximately 1~2 weeks.
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To access the safety and tolerability of multiple ascending oral dose of XH-S004 in healthy adults.
Tidsramme: Approximately 2 months.
|
The incidence and severity of adverse events (AEs) , serious AEs and abnormalities on laboratory tests. |
Approximately 2 months.
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Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- XH-S004-101
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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