- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07935291
Study of IPG1094 Tablets in Chinese Healthy Adults and Obese Adults
A Phase Ⅰ Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Weight-Loss Effect of IPG1094 Tablets in Chinese Healthy Adults and Obese Adult Participants
This is a Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics and preliminary weight-loss effect of IPG1094 tablets. The study includes three parts: Part A is single ascending dose in healthy volunteers; Part B is multiple ascending dose in healthy volunteers; Part C is multiple-dose exploration in obese adult participants. Subjects will be randomly assigned to receive IPG1094 or matching placebo. Safety, blood drug concentration and weight-related indicators will be followed up.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Тип исследования
Регистрация (Оцененный)
Фаза
- Фаза 1
Контакты и местонахождение
Контакты исследования
- Имя: qiaofeng qu
- Номер телефона: +86 021-34782827
- Электронная почта: qfqu@immunophage.com.cn
Места учебы
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Zhejiang
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Hangzhou, Zhejiang, Китай, 310013
- Zhejiang Hospital
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Контакт:
- Wanggang Zhang, Master
- Номер телефона: +86 13738194591
- Электронная почта: zhangwgnian@126.com
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Male and female Chinese participants aged 18-50 years inclusive.
- Part A/B (healthy adults): Physical examination, vital signs, 12-lead ECG, chest X-ray, laboratory tests are normal or abnormalities considered not clinically significant by investigator; male body weight ≥50.0 kg, female ≥45.0 kg; BMI 19.0-26.0 kg/m².
- Part C (obese adults): BMI 28.0-35.0 kg/m²; body weight stable within 3 months prior to screening (weight change ≤5%). No concomitant diseases interfering with safety, PK or weight evaluation.
- Female participants are non-pregnant and non-lactating.
- All participants (male and female) agree to use effective contraception from informed consent through 6 months after last study drug administration; no plan for pregnancy, sperm / oocyte donation.
- For Part C: Able to complete hospitalization for first 10 days, outpatient visits, home drug administration and study diary; refrain from additional weight-loss medications, bariatric surgery or intensive weight-loss programs.
- Voluntarily sign written informed consent form.
Exclusion Criteria:
- History of severe/uncontrolled cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immune, dermatological, neurological or psychiatric diseases with ongoing clinical significance.
- ECG: QTcF >450 ms (male) / >470 ms (female).
- Recurrent headache/migraine, recurrent nausea/vomiting.
- Blood donation ≥400 mL within 3 months before screening.
- History of orthostatic hypotension, dysphagia.
- Gastrointestinal disorders affecting drug absorption.
- Cannot comply with unified diet requirements, lactose intolerance.
- Major surgery within 3 months before screening or planned surgery during study.
- Known hypersensitivity to study drug or placebo excipients.
- Alcohol or substance abuse history; positive drug-of-abuse screen or positive alcohol breath test.
- Excessive alcohol / tobacco / caffeine intake defined per protocol.
- Use of metformin or other biguanides within 3 months before screening; systemic glucocorticoids within 1 month before screening; CYP-modifying drugs within 30 days before screening; prescription/OTC/herbal products within 14 days before screening.
- Consumption of grapefruit / citrus fruits/juice within 5 days pre-screening and refusal to abstain during study.
- Vaccines or biological agents within 4 months pre-screening or planned during study.
- Participation in another interventional clinical trial within 3 months before screening.
- Difficult venous access, history of needle-phobia.
- Acute disease within 14 days prior to screening.
- Other conditions judged inappropriate for enrollment by investigator. Additional Exclusion for Part C (obese participants): Fasting glucose ≥11.0 mmol/L or HbA1c ≥8.0%; secondary obesity, eating disorders, clinically significant cardiovascular disease, moderate-severe obstructive sleep apnea, active liver disease, significant renal impairment.
Repeated BP: SBP ≥160 mmHg or DBP ≥100 mmHg; ALT/AST >2×ULN; total bilirubin >1.5×ULN; eGFR <60 mL/min/1.73 m².
Weight-loss drugs, intensive weight-loss program within 3-month pre-screening; prior or planned bariatric surgery.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Последовательное назначение
- Маскировка: Четырехместный
Оружие и интервенции
Группа участников / Армия |
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Экспериментальный: Part-A-100 mg Cohort
Drug: IPG1094 Tablet 100 mg,single oral dose, fasted condition;Drug: Matching Placebo Tablet,single oral dose, fasted condition |
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Экспериментальный: Part-A-300 mg Cohort
Drug: IPG1094 Tablet 300 mg,single oral dose, fasted condition;Drug: Matching Placebo Tablet,single oral dose, fasted condition |
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Экспериментальный: Part-B1-50 mg QD Cohort
Drug: IPG1094 Tablet 50 mg QD, post-meal for 10 days;Drug: Matching Placebo Tablet QD, post-meal for 10 days |
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Экспериментальный: Part-B2-100 mg QD Cohort
Drug: IPG1094 Tablet 100 mg QD, post-meal for 10 days;Drug: Matching Placebo Tablet QD, post-meal for 10 days |
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Экспериментальный: Part-B3-200 mg QD Cohort
Drug: IPG1094 Tablet 200 mg QD, post-meal for 10 days;Drug: Matching Placebo Tablet QD, post-meal for 10 days |
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Экспериментальный: Part-B4-100 mg BID Optional Cohort(optional, depends on safety/PK data)
Drug: IPG1094 Tablet 100 mg BID post-meal;Drug: Matching Placebo Tablet BID post-meal |
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Экспериментальный: Part-C1-100 mg QD Obese Cohort
Drug: IPG1094 Tablet 100 mg QD post-meal for 28 days;Drug: Matching Placebo Tablet QD post-meal for 28 days |
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Экспериментальный: Part-C2-200 mg QD Obese Cohort
Drug: IPG1094 Tablet 200 mg QD post-meal for 28 days;Drug: Matching Placebo Tablet QD post-meal for 28 days |
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Экспериментальный: Part-C3-300 mg QD Obese Cohort
Drug: IPG1094 Tablet 300 mg QD post-meal for 90 days;Drug: Matching Placebo Tablet QD post-meal for 90 days |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Part A: Maximum Observed Plasma Concentration (Cmax) of IPG1094 after single dose
Временное ограничение: Up to 96 hours post-dose
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Single-dose maximum observed plasma concentration (Cmax) of IPG1094 following oral administration in healthy adult participants. |
Up to 96 hours post-dose
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Part A: Time to Maximum Plasma Concentration (Tmax) of IPG1094 after single dose
Временное ограничение: Up to 96 hours post-dose
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Single-dose time to reach maximum plasma concentration (Tmax) of IPG1094 following oral administration in healthy adult participants. |
Up to 96 hours post-dose
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Part A: Terminal Elimination Half-life (t1/2) of IPG1094 after single dose
Временное ограничение: Up to 96 hours post-dose
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Single-dose terminal elimination half-life (t1/2) of IPG1094 following oral administration in healthy adult participants. |
Up to 96 hours post-dose
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Part A: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of IPG1094 in Part A
Временное ограничение: Up to 96 hours post-dose
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Single-dose AUC0-t of IPG1094 following oral administration in healthy adult participants. |
Up to 96 hours post-dose
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Part A: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of IPG1094 in Part A
Временное ограничение: Up to 96 hours post-dose
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Single-dose AUC0-inf of IPG1094 following oral administration in healthy adult participants. |
Up to 96 hours post-dose
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Part A: Apparent Oral Clearance (CL/F) of IPG1094 in Part A
Временное ограничение: Up to 96 hours post-dose
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Single-dose apparent oral clearance (CL/F) of IPG1094 following oral administration in healthy adult participants. |
Up to 96 hours post-dose
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Steady-State Maximum Observed Plasma Concentration (Css,max) of IPG1094 in Part B
Временное ограничение: Day 1 to Day 13
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Multiple-dose steady-state maximum observed plasma concentration (Css,max) of IPG1094 after repeated oral dosing in healthy adult participants. |
Day 1 to Day 13
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Time to Steady-State Maximum Plasma Concentration (Tss,max) of IPG1094 in Part B
Временное ограничение: Day 1 to Day 13
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Multiple-dose time to steady-state maximum plasma concentration (Tss,max) of IPG1094 after repeated oral dosing in healthy adult participants. |
Day 1 to Day 13
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Area Under the Plasma Concentration-Time Curve Over One Dosing Interval at Steady State (AUC0-τ) of IPG1094 in Part B
Временное ограничение: Day 1 to Day 13
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Multiple-dose steady-state AUC0-τ of IPG1094 after repeated oral dosing in healthy adult participants. |
Day 1 to Day 13
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Steady-State Apparent Oral Clearance (CLss/F) of IPG1094 in Part B
Временное ограничение: Day 1 to Day 13
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Multiple-dose steady-state apparent oral clearance (CLss/F) of IPG1094 after repeated oral dosing in healthy adult participants. |
Day 1 to Day 13
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Accumulation Index Based on AUC (Rac,AUC) of IPG1094 in Part B
Временное ограничение: Day 1 to Day 13
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Accumulation index calculated using AUC (Rac,AUC) of IPG1094 after repeated oral dosing in healthy adult participants. |
Day 1 to Day 13
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Accumulation Index Based on Cmax (Rac,Cmax) of IPG1094 in Part B
Временное ограничение: Day 1 to Day 13
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Accumulation index calculated using Cmax(Rac,Cmax) of IPG1094 after repeated oral dosing in healthy adult participants. |
Day 1 to Day 13
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Safety indicators:adverse event
Временное ограничение: Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
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Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
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Вторичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
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Part A: Safety indicators:adverse event
Временное ограничение: Up to 8-day follow-up
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Up to 8-day follow-up
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Part B: Safety indicators:adverse event
Временное ограничение: Up to Day16 follow-up
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Up to Day16 follow-up
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Part C: Percentage change from baseline in body weight on Day 30 for the 100 mg QD and 200 mg QD cohorts
Временное ограничение: Day30 for 100/200 mg QD groups
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Day30 for 100/200 mg QD groups
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Part C: Percentage change from baseline in body weight on Day 90 for the 300 mg QD cohort.
Временное ограничение: Day90 for 300 mg QD group
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Day90 for 300 mg QD group
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Part C: Changes from baseline in body weight (kg) across all scheduled visits
Временное ограничение: Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
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Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
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Part C: Changes from baseline BMI across all scheduled visits
Временное ограничение: Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
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Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
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Part C: Changes from baseline waist circumference across all scheduled visits
Временное ограничение: Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
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Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
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Part C: proportion of subjects achieving ≥5% weight loss from baseline at the endpoint assessment.
Временное ограничение: Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
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Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
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Part C: Cmax following first and last dosing.
Временное ограничение: Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
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Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
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Part C: Tmax following first and last dosing.
Временное ограничение: Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
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Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
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Part C: AUC₀-τ following the first dose and last dose
Временное ограничение: Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
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Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
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Part C: Accumulation index
Временное ограничение: Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
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Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
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Соавторы и исследователи
Соавторы
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- IPG1094-HV-C002
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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