- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07936032
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).
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 1
Kontakty a umístění
Studijní kontakt
- Jméno: Lifei Liu
- Telefonní číslo: +86-27-87173753
- E-mail: liulifei@renfu.com.cn
Studijní místa
-
-
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Shanghai, Čína
- Huashan Hospital, Fudan University
-
Kontakt:
- Jing Zhang
- Telefonní číslo: +86-21-52887926
- E-mail: Zhangj_fudan@163.com
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Part A:HW281171
Single dose of HW281171 tablets |
Administered orally daily at pre-specified dose and frequency. |
|
Komparátor placeba: Part A:Placebo
Single dose of Placebo tablets |
Administered orally daily at pre-specified dose and frequency. |
|
Experimentální: Part B:Sequence A
Single dose of HW281171 tablets under fasting-fed sequence |
Administered orally daily at pre-specified dose and frequency. |
|
Experimentální: Part B:Sequence B
Single dose of HW281171 tablets under fed-fasting sequence |
Administered orally daily at pre-specified dose and frequency. |
|
Experimentální: Part C:HW281171
Multiple doses of HW281171 tablets |
Administered orally daily at pre-specified dose and frequency. |
|
Komparátor placeba: Part C:Placebo
Multiple doses of Placebo tablets |
Administered orally daily at pre-specified dose and frequency. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
The number and severity of treatment emergent adverse events (TEAEs)
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
The maximum serum concentration (Cmax)
Časové okno: 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)
Časové okno: Up to 1 month
|
Pharmacokinetic parameter |
Up to 1 month
|
|
The time to reach Cmax (Tmax)
Časové okno: Up to 1 month
|
Pharmacokinetic parameter |
Up to 1 month
|
|
The Half life (t1/2)
Časové okno: Up to 1 month
|
Pharmacokinetic parameter |
Up to 1 month
|
Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- HW281171-101
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Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
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