- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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).
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Typ studiów
Zapisy (Szacowany)
Faza
- Faza 1
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Lifei Liu
- Numer telefonu: +86-27-87173753
- E-mail: liulifei@renfu.com.cn
Lokalizacje studiów
-
-
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Shanghai, Chiny
- Huashan Hospital, Fudan University
-
Kontakt:
- Jing Zhang
- Numer telefonu: +86-21-52887926
- E-mail: Zhangj_fudan@163.com
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-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Part A:HW281171
Single dose of HW281171 tablets |
Administered orally daily at pre-specified dose and frequency. |
|
Komparator placebo: Part A:Placebo
Single dose of Placebo tablets |
Administered orally daily at pre-specified dose and frequency. |
|
Eksperymentalny: Part B:Sequence A
Single dose of HW281171 tablets under fasting-fed sequence |
Administered orally daily at pre-specified dose and frequency. |
|
Eksperymentalny: Part B:Sequence B
Single dose of HW281171 tablets under fed-fasting sequence |
Administered orally daily at pre-specified dose and frequency. |
|
Eksperymentalny: Part C:HW281171
Multiple doses of HW281171 tablets |
Administered orally daily at pre-specified dose and frequency. |
|
Komparator placebo: Part C:Placebo
Multiple doses of Placebo tablets |
Administered orally daily at pre-specified dose and frequency. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
The number and severity of treatment emergent adverse events (TEAEs)
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
The maximum serum concentration (Cmax)
Ramy czasowe: 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)
Ramy czasowe: Up to 1 month
|
Pharmacokinetic parameter |
Up to 1 month
|
|
The time to reach Cmax (Tmax)
Ramy czasowe: Up to 1 month
|
Pharmacokinetic parameter |
Up to 1 month
|
|
The Half life (t1/2)
Ramy czasowe: Up to 1 month
|
Pharmacokinetic parameter |
Up to 1 month
|
Współpracownicy i badacze
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- HW281171-101
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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