- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07760467
To Evaluate Safety, Tolerability, PK/PD & Food Effect of Single/Multiple Oral TUL321 Capsules in Healthy Participants.
30 augusti 2026 uppdaterad 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
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Primary Objective:
To evaluate the safety and tolerability following single and multiple oral dministrations of TUL321 capsules in healthy participants.
Secondary Objectives:
- To characterize the pharmacokinetic (PK) profiles following single and multiple oral administrations of TUL321 capsules in healthy participants;
- To evaluate the effect of a high-fat meal on the PK profiles after a single oral administration of TUL321 capsules in healthy participants;
- To preliminarily assess the in vivo biotransformation and mass balance characteristics following single oral administration of TUL321 capsules;
- To characterize the pharmacodynamic (PD) profiles following single and multiple oral administrations of TUL321 capsules in healthy participants;
- To evaluate the effect of single oral administration of TUL321 capsules on the QT/QTc interval.
Studietyp
Interventionell
Inskrivning (Beräknad)
94
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Guoping Yang
- Telefonnummer: +86-13974817168
- E-post: ygp9880@163.com
Studieorter
-
-
Hunan
-
Changsha, Hunan, Kina
- Rekrytering
- Third Xiangya Hospital of Central South University
-
Kontakt:
- Guoping Yang
- Telefonnummer: +86-13974817168
- E-post: ygp9880@163.com
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Ja
Beskrivning
Inclusion Criteria:
- 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.
- Age 18-45 years (inclusive) at informed consent, male or female.
- Weight ≥50.0 kg for males, ≥45.0 kg for females; BMI 19.0-26.0 kg/m² (inclusive).
- 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.
- 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:
- Suspected or confirmed allergy to investigational product or its similar components; or history of multiple drug/food allergies.
- Past history of tuberculosis infection or active tuberculosis at screening.
- Known or suspected history of immunodeficiency, inherited or acquired complement deficiency.
- Confirmed active systemic bacterial, viral or fungal infection within 2 weeks before screening.
- History of confirmed encapsulated bacterial infection within 6 months before screening, including but not limited to meningococcus, streptococcus pneumoniae, Haemophilus influenzae type b.
- Clinically significant abnormal findings in laboratory tests, physical examination, vital signs, ECG, chest X-ray or abdominal ultrasound at screening.
- 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.
- eGFR <90 mL/min/1.73 m² (calculated by CKD-EPI formula) at screening.
- Positive for HBsAg, anti-HCV, anti-HIV or syphilis-specific antibody at screening.
- Received other vaccines not specified in the protocol within 1 month before screening, or plan to receive such vaccines during the study.
- 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).
- Average daily cigarette consumption >5 cigarettes within 3 months before screening.
- History of drug/substance abuse within 6 months before screening, or positive drug abuse screening test.
- Chronic constipation or diarrhea, or other conditions judged by investigator to interfere with fecal sample collection.
- Required or plan to perform heavy physical labor or strenuous exercise during study participation.
- Pregnant or lactating women, or women of child-bearing potential with positive pregnancy test at screening.
- Acute illness or concomitant medication occurs from screening to pre-first-dose.
- Cannot tolerate high-fat meal (applies only to subjects in the food-effect sub-study).
- Difficulty swallowing, intolerance to venipuncture, or history of needle-syncope or blood-syncope.
- Investigator judges that the subject is unsuitable for this study for any other reason.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Sekventiell tilldelning
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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
Andra namn:
orally, 50 mg QD、100 mg QD、300 mg QD、50 mg BID
Andra namn:
|
|
Placebo-jämförare: 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
Andra namn:
Oral placebo capsules matching TUL321 capsules
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
1.Incidence of adverse events (AEs) 2.Changes from baseline in physical examinations, vital signs, electrocardiograms (ECG), and laboratory tests
Tidsram: up to 17 days
|
up to 17 days
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Peak plasma concentration (Cmax)
Tidsram: Pre-dose to 144 hours post-dose
|
Pre-dose to 144 hours post-dose
|
|
Time to maximum plasma concentration (Tmax)
Tidsram: Pre-dose to 144 hours post-dose
|
Pre-dose to 144 hours post-dose
|
|
Cumulative amount excreted(Ae)in urine
Tidsram: Pre-dose to 144 hours post-dose
|
Pre-dose to 144 hours post-dose
|
|
Cumulative amount excreted(Ae)in feces
Tidsram: Pre-dose to 144 hours post-dose
|
Pre-dose to 144 hours post-dose
|
|
Alternative pathway (AP) activity
Tidsram: Pre-dose to 144 hours post-dose
|
Pre-dose to 144 hours post-dose
|
|
Bb concentration
Tidsram: Pre-dose to 144 hours post-dose
|
Pre-dose to 144 hours post-dose
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Guoping Yang, The Third XIANGYA Hospital of Central South University
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
26 augusti 2026
Primärt slutförande (Beräknad)
8 maj 2027
Avslutad studie (Beräknad)
8 maj 2027
Studieregistreringsdatum
Först inskickad
4 augusti 2026
Först inskickad som uppfyllde QC-kriterierna
9 augusti 2026
Första postat (Faktisk)
12 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
1 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
30 augusti 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- TUL-TUL321(I-2)202605
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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