Набор скоро начнётся NCT06951880

A Study to Investigate the Safety and Pharmacokinetics of Single- and Multiple-ascending Doses of AZD4916 in Healthy Volunteers

Фаза I С лечением Healthy Participants

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: AZD4916, Placebo.
Кому может быть актуально: Состояния в реестре: Healthy Participants. Базовые параметры: 18 лет — 55 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Великобритания
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Phase I, Randomized, Single-blind, Placebo-controlled, 2-Part Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD4916 Following Single- and Multiple-ascending-dose Administration to Healthy Adult Volunteers (Including Japanese and Chinese Healthy Volunteers)

Обзор

The main purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) of AZD4916 in healthy adult participants.

Подробное описание

This is a single-blind, placebo-controlled study conducted at a single clinical unit.

The study will comprise of:

* Part 1: Single ascending dose (SAD) part (part 1a) and a Multiple ascending dose (MAD) part (part 1b), both in global participants. * Part 2: SAD part (part 2a) and a MAD part (part 2b) specifically for Japanese and Chinese participants only.

Вмешательства

Препарат AZD4916
AZD4916 will be administered as oral solution.
Другое Placebo
Placebo will be administered as oral solution.

Первичные конечные точки

Number of participants with adverse events (AEs) [Срок оценки: From Screening (Day -29 to Day -2) up to 44 days]

Вторичные конечные точки (4)

Area under concentration-time curve from time zero to infinity (AUCinf) [Срок оценки: Part 1a and 2a: Up to Day 8, Part 1b and 2b: Up to Day 24]
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast) [Срок оценки: Part 1a and 2a: Up to Day 8, Part 1b and 2b: Up to Day 24]
Area under concentration-time curve in the dosing interval (AUCtau) [Срок оценки: Part 1a and 2a: Up to Day 8, Part 1b and 2b: Up to Day 24]
Maximum observed drug concentration (Cmax) [Срок оценки: Part 1a and 2a: Up to Day 8, Part 1b and 2b: Up to Day 24]

Критерии участия

Main Inclusion Criteria:

Healthy male and female participants with suitable veins for cannulation or repeated venipuncture.
All females must have negative pregnancy test and females of childbearing potential must not be lactating and must agree to use an approved method of highly effective contraception.
Have a Body Mass Index between 18 and 30 kg/m2 inclusive and weigh at least 45 kg at Screening.
Part 2, Japanese participants only: Japanese participants must have been born in Japan, have 2 Japanese biological parents and 4 Japanese grandparents (as confirmed by the interview), and must not have lived outside of Japan for more than 10 years at the time of the Screening Visit.
Part 2, Chinese participants only: Chinese participants must have been born in China (including Hong Kong, Macau, and Taiwan), have 2 Chinese biological parents and 4 Chinese grandparents (as confirmed by the interview), and must not have lived outside of China for more than 10 years at the time of the Screening Visit.

Main Exclusion Criteria:

History of any clinically important disease or disorder which, in the opinion of the Principal Investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
History of chest irradiation, fibrosis, malignancy, surgical procedure, trauma or liver disease.
Any clinically important abnormalities in clinical chemistry, hematology, or urinalysis results.
Evidence of active tuberculosis or Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) or Hepatitis C virus (HCV) infection.
Abnormal vital signs or clinically important abnormalities in rhythm.
Current smokers, known or suspected history of alcohol, drug abuse or caffeine intake.
History of severe allergy/hypersensitivity.
Plasma donation within 1 month of the Screening Visit or any blood donation/blood loss > 500 mL during the 3 months prior to the Screening Visit.
Participants who are vegans or have dietary restrictions.
Vulnerable participants, e.g., kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да