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Phase I Study to Evaluate Single and Multiple Oral Doses of HW281171 Tablets in Healthy Participants

A Phase I Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetic Profiles of Single and Multiple Oral Administration and Dose Escalation of HW281171 Tablets in Healthy Participants

This phase 1 study aims to evaluate the safety, tolerability and pharmacokinetic profiles of HW281171 in healthy Participants. The study consists of three parts: Part A (Single-Dose Escalation Study), Part B (Food Effect and Metabolite Study), and Part C (Multiple-Dose Escalation Study).

Studie Overzicht

Toestand

Nog niet aan het werven

Studietype

Ingrijpend

Inschrijving (Geschat)

80

Fase

  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

      • Shanghai, China
        • Huashan Hospital, Fudan University
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 45 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Participants sign the informed consent form prior to the initiation of any study procedures.
  • Healthy male and female participants aged 18 to 45 years (inclusive), with no less than 3 participants of a single gender.
  • Female participants have a body weight of ≥45.00 kg, male participants have a body weight of ≥50.00 kg, and the body mass index (BMI) ranges from 19.0 to 26.0 kg/m^2 (inclusive).
  • Participants whose vital signs, physical examination, 12-lead electrocardiogram, laboratory tests, abdominal B-ultrasound and posteroanterior chest X-ray results at screening or on Day -1 are judged by the Investigator to be normal or abnormal without clinical significance.
  • Participants agree to have no fertility plan and no sperm/egg donation plan from the time of signing the informed consent form until 3 months after study withdrawal, and are willing to practice abstinence or use highly effective contraceptive methods during this period.
  • Participants can communicate well with the Investigator, understand and comply with all requirements of this study, and fully understand the study purpose, nature, methods and potential Adverse Events.

Exclusion Criteria:

  • Participants with a history of drug or food allergy, allergic diseases, or allergic diathesis (allergic to two or more substances), or with confirmed allergy to any component or analogue of the investigational product.
  • Participants with any past or current clinically significant severe or chronic diseases of the circulatory, endocrine, nervous, digestive, respiratory, hematological, immune, psychiatric systems or metabolic disorders, or any other diseases judged by the investigator that may interfere with trial results.
  • Participants with a history of gastrointestinal, hepatic or renal diseases affecting drug absorption or metabolism, or known or suspected diseases affecting drug intake, transport, absorption, distribution, metabolism or excretion; participants who have undergone surgeries affecting drug absorption or metabolism (appendectomy excluded).
  • Participants with abnormal examination results specified in the protocol at screening or on Day -1.
  • Participants with a history of drug abuse, drug dependence, or positive drug screening results.
  • Participants with positive results for any of human immunodeficiency virus antibody, hepatitis B virus surface antigen, hepatitis C virus antibody, or treponema pallidum specific antibody.
  • Female participants who are pregnant, lactating at screening or during the trial, or have a pregnancy test result above the upper limit of normal, or have had unprotected sexual intercourse within 2 weeks before screening.
  • Participants with prior or concomitant medications/non-drug interventions specified in the protocol.
  • Participants who have participated in any clinical trial of drugs or medical devices within 90 days before screening (participation in a clinical trial is defined as receiving or using the investigational drug/device).
  • Participants with severe trauma or surgical operation within 3 months before screening; participants who plan to receive surgery during the trial or within two weeks after trial completion.
  • Participants who have donated blood or experienced a total blood loss of ≥400 ml within 3 months before the first dose.
  • Participants with difficult venous access and intolerance to venipuncture.
  • Participants with a smoking history within 3 months before screening (average daily consumption >5 cigarettes), or who cannot stop using any tobacco products during the trial.
  • Participants with an average weekly alcohol intake of more than 14 alcohol units within 3 months before screening (1 alcohol unit is approximately 360 ml beer, or 45 ml spirits with 40 Percentage alcohol content, or 150 ml wine), or positive alcohol breath test, or who cannot abstain from alcohol during the trial.
  • Participants consuming excessive tea, coffee or caffeinated beverages on average every day (more than 8 cups, 1 cup = 250 ml) within 48 hours before the first dose, or who cannot stop consuming tea, coffee or caffeinated beverages during the trial; participants who have consumed special diets within 48 hours before the first dose (including pitaya, mango, lime, pomelo, carambola, orange, grapefruit or grapefruit products and other fruits or corresponding juices that may affect drug metabolism), or other special diets affecting drug absorption, distribution, metabolism or excretion.
  • Participants with special dietary requirements and unable to follow the unified diet.
  • Participants with other factors judged by the investigator to be unsuitable for participating in the clinical trial.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Part A:HW281171

Single dose of HW281171 tablets

Administered orally daily at pre-specified dose and frequency.

Placebo-vergelijker: Part A:Placebo

Single dose of Placebo tablets

Administered orally daily at pre-specified dose and frequency.

Experimenteel: Part B:Sequence A

Single dose of HW281171 tablets under fasting-fed sequence

Administered orally daily at pre-specified dose and frequency.

Experimenteel: Part B:Sequence B

Single dose of HW281171 tablets under fed-fasting sequence

Administered orally daily at pre-specified dose and frequency.

Experimenteel: Part C:HW281171

Multiple doses of HW281171 tablets

Administered orally daily at pre-specified dose and frequency.

Placebo-vergelijker: Part C:Placebo

Multiple doses of Placebo tablets

Administered orally daily at pre-specified dose and frequency.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
The number and severity of treatment emergent adverse events (TEAEs)
Tijdsspanne: Up to 1 month

To assess the safety and tolerability of single or multiple doses of HW281171 tablets in healthy participants.

Up to 1 month

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
The maximum serum concentration (Cmax)
Tijdsspanne: Up to 1 month

Pharmacokinetic parameter

Up to 1 month
The Area Under the Curve from dosing to the time of the last measured concentration (AUC0-t)
Tijdsspanne: Up to 1 month

Pharmacokinetic parameter

Up to 1 month
The time to reach Cmax (Tmax)
Tijdsspanne: Up to 1 month

Pharmacokinetic parameter

Up to 1 month
The Half life (t1/2)
Tijdsspanne: Up to 1 month

Pharmacokinetic parameter

Up to 1 month

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

18 november 2026

Primaire voltooiing (Geschat)

1 augustus 2027

Studie voltooiing (Geschat)

1 september 2027

Studieregistratiedata

Eerst ingediend

5 november 2026

Eerst ingediend dat voldeed aan de QC-criteria

11 november 2026

Eerst geplaatst (Werkelijk)

13 november 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

13 november 2026

Laatste update ingediend die voldeed aan QC-criteria

11 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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