Идёт набор NCT07566338

A Study of LY4302814 in Healthy Participants

Фаза I С лечением Healthy

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: LY4302814, LY4302814, Placebo, Placebo.
Кому может быть актуально: Состояния в реестре: Healthy. Базовые параметры: 18 лет — 65 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, Сингапур
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 1, Randomized, Placebo-Controlled, Investigator and Participant Blinded, Single Ascending Dose and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY4302814 in Healthy Participants

Обзор

The main purpose of this study is to assess how well LY4302814 is tolerated and what side effects may occur in healthy participants. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. For each participant, the study will last about 6 months and will include at least one overnight stay in the clinical research unit (CRU) lasting up to approximately 9 days.

Вмешательства

Препарат LY4302814
Administered SC
Препарат LY4302814
Administered IV
Препарат Placebo
Administered SC
Препарат Placebo
Administered IV

Первичные конечные точки

Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [Срок оценки: Day 1 through Day 197]

Вторичные конечные точки (2)

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY4302814 [Срок оценки: Day 1 through Day 197]
PK: Maximum Concentration (Cmax) of LY4302814 [Срок оценки: Day 1 through Day 197]

Критерии участия

Критерии включения

Are overtly healthy as determined by medical evaluation.
Have clinical laboratory test results within the normal range for the population or investigative site or with abnormalities deemed not clinically significant by the investigator.
Have a body weight of 45 kilograms (kg) or greater and body mass index within 18 to 32 kilogram per square meter (kg/m ²), inclusive.
Are individuals assigned female at birth (AFAB) and not of childbearing potential, and individuals assigned male at birth (AMAB). Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Adult participants in Singapore:

Are 21 years of age or older.

Критерии исключения

Evidence or history of clinically significant conditions.
Have a 12-lead electrocardiogram (ECG) abnormality, that, in the opinion of the investigator, increases the risks associated with participating in the study or may confound ECG data analysis.
Show evidence of hepatitis B virus (HBV) infection with a positive hepatitis B surface antigen (HBsAg) or anti-hepatitis B core (HBc).
Show evidence of hepatitis C virus (HCV) infection, with positive anti-HCV.
Have human immunodeficiency virus (HIV) infection or positive HIV-1 and HIV-2 antibodies.
Have used or intend to use herbal, vitamin supplements, over-the-counter or prescription medication, within 14 days or 5 half-lives (whichever is longer) prior to dosing and during the study, unless, in the opinion of the investigator and sponsor, the medication will not interfere with the study.
Smoke more than 5 cigarettes a day, or the equivalent in nicotine-containing products, and/or are unable to abide by clinical research unit (CRU) smoking restrictions.
Have alcohol intake that exceeds recommended average weekly alcohol consumption limits per local regulation, or an amount deemed significant by the investigator.

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

Здоровые добровольцы: Да