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To Evaluate Safety, Tolerability, PK/PD & Food Effect of Single/Multiple Oral TUL321 Capsules in Healthy Participants.

30. august 2026 oppdatert av: Zhuhai United Laboratories Co., Ltd.

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Characteristics of Single and Multiple Doses of TUL321 Capsule in Healthy Participants, and the Effect of Food on Pharmacokinetics

Phase I Study Evaluating Safety, Tolerability, PK and PD of Single and Multiple Doses of TUL321 Capsule in Healthy Participants and Food Effect on PK

Studieoversikt

Detaljert beskrivelse

Primary Objective:

To evaluate the safety and tolerability following single and multiple oral dministrations of TUL321 capsules in healthy participants.

Secondary Objectives:

  1. To characterize the pharmacokinetic (PK) profiles following single and multiple oral administrations of TUL321 capsules in healthy participants;
  2. To evaluate the effect of a high-fat meal on the PK profiles after a single oral administration of TUL321 capsules in healthy participants;
  3. To preliminarily assess the in vivo biotransformation and mass balance characteristics following single oral administration of TUL321 capsules;
  4. To characterize the pharmacodynamic (PD) profiles following single and multiple oral administrations of TUL321 capsules in healthy participants;
  5. To evaluate the effect of single oral administration of TUL321 capsules on the QT/QTc interval.

Studietype

Intervensjonell

Registrering (Antatt)

94

Fase

  • Fase 1

Kontakter og plasseringer

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

Studiekontakt

  • Navn: Guoping Yang
  • Telefonnummer: +86-13974817168
  • E-post: ygp9880@163.com

Studiesteder

    • Hunan
      • Changsha, Hunan, Kina
        • Rekruttering
        • Third Xiangya Hospital of Central South University
        • Ta kontakt med:

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

Tar imot friske frivillige

Ja

Beskrivelse

Inclusion Criteria:

  1. Participants can communicate well with investigators, fully understand the study, volunteer to take part, comply with all study requirements, and sign written informed consent before study procedures.
  2. Age 18-45 years (inclusive) at informed consent, male or female.
  3. Weight ≥50.0 kg for males, ≥45.0 kg for females; BMI 19.0-26.0 kg/m² (inclusive).
  4. Female participants with child-bearing potential, and male participants whose partners have child-bearing potential: no pregnancy, sperm or egg donation from consent to 3 months after last dose, and willing to use study-required contraception.
  5. For MAD-only participants: receive ACYW135 meningococcal vaccine and pneumococcal vaccine at least 14 days before first dose. No re-vaccination is needed if pneumococcal vaccine was given within 5 years, or ACYW135 meningococcal vaccine within 3 years prior to first dose.

Exclusion Criteria:

  1. Suspected or confirmed allergy to investigational product or its similar components; or history of multiple drug/food allergies.
  2. Past history of tuberculosis infection or active tuberculosis at screening.
  3. Known or suspected history of immunodeficiency, inherited or acquired complement deficiency.
  4. Confirmed active systemic bacterial, viral or fungal infection within 2 weeks before screening.
  5. History of confirmed encapsulated bacterial infection within 6 months before screening, including but not limited to meningococcus, streptococcus pneumoniae, Haemophilus influenzae type b.
  6. Clinically significant abnormal findings in laboratory tests, physical examination, vital signs, ECG, chest X-ray or abdominal ultrasound at screening.
  7. QTcF (Fridericia correction) ≥450 ms at screening; or other risk factors for torsades de pointes (TdP), such as heart failure, hypokalemia, hypomagnesemia, family history of long QT syndrome.
  8. eGFR <90 mL/min/1.73 m² (calculated by CKD-EPI formula) at screening.
  9. Positive for HBsAg, anti-HCV, anti-HIV or syphilis-specific antibody at screening.
  10. Received other vaccines not specified in the protocol within 1 month before screening, or plan to receive such vaccines during the study.
  11. Participated in another interventional clinical trial within 3 months before screening (excluding subjects who only completed screening without enrollment, or enrolled but did not receive study treatment).
  12. Average daily cigarette consumption >5 cigarettes within 3 months before screening.
  13. History of drug/substance abuse within 6 months before screening, or positive drug abuse screening test.
  14. Chronic constipation or diarrhea, or other conditions judged by investigator to interfere with fecal sample collection.
  15. Required or plan to perform heavy physical labor or strenuous exercise during study participation.
  16. Pregnant or lactating women, or women of child-bearing potential with positive pregnancy test at screening.
  17. Acute illness or concomitant medication occurs from screening to pre-first-dose.
  18. Cannot tolerate high-fat meal (applies only to subjects in the food-effect sub-study).
  19. Difficulty swallowing, intolerance to venipuncture, or history of needle-syncope or blood-syncope.
  20. Investigator judges that the subject is unsuitable for this study for any other reason.

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Sekvensiell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: TUL321
Healthy participants take oral TUL321 capsules: Part1 single ascending doses, Part2 multiple daily doses to assess safety, tolerability, PK, PD and food effect.
orally, 20 mg、50 mg、 100 mg、200 mg、400 mg and 600 mg
Andre navn:
  • TUL321
orally, 50 mg QD、100 mg QD、300 mg QD、50 mg BID
Andre navn:
  • TUL321
Placebo komparator: Placebo
Healthy participants receive oral placebo capsules matching TUL321 capsules in Part 1 and Part 2, administered in parallel with TUL321 treatment cohorts as control.
Oral placebo capsules matching TUL321 capsules
Andre navn:
  • Placebo
Oral placebo capsules matching TUL321 capsules
Andre navn:
  • Placebo

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
1.Incidence of adverse events (AEs) 2.Changes from baseline in physical examinations, vital signs, electrocardiograms (ECG), and laboratory tests
Tidsramme: up to 17 days
up to 17 days

Sekundære resultatmål

Resultatmål
Tidsramme
Peak plasma concentration (Cmax)
Tidsramme: Pre-dose to 144 hours post-dose
Pre-dose to 144 hours post-dose
Time to maximum plasma concentration (Tmax)
Tidsramme: Pre-dose to 144 hours post-dose
Pre-dose to 144 hours post-dose
Cumulative amount excreted(Ae)in urine
Tidsramme: Pre-dose to 144 hours post-dose
Pre-dose to 144 hours post-dose
Cumulative amount excreted(Ae)in feces
Tidsramme: Pre-dose to 144 hours post-dose
Pre-dose to 144 hours post-dose
Alternative pathway (AP) activity
Tidsramme: Pre-dose to 144 hours post-dose
Pre-dose to 144 hours post-dose
Bb concentration
Tidsramme: Pre-dose to 144 hours post-dose
Pre-dose to 144 hours post-dose

Samarbeidspartnere og etterforskere

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

Etterforskere

  • Hovedetterforsker: Guoping Yang, The Third XIANGYA Hospital of Central South 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)

26. august 2026

Primær fullføring (Antatt)

8. mai 2027

Studiet fullført (Antatt)

8. mai 2027

Datoer for studieregistrering

Først innsendt

4. august 2026

Først innsendt som oppfylte QC-kriteriene

9. august 2026

Først lagt ut (Faktiske)

12. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

1. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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