Идёт набор NCT07501039

A Phase 1 Study of BLKR201 in Healthy Adult 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: BLKR201, BLKR201, BLKR201, Placebo.
Кому может быть актуально: Состояния в реестре: Healthy. 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
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, Double-Blind, Placebo-Controlled, Single and Multiple Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BLKR201 in Healthy Adult Participants

Обзор

The goal of this clinical trial is to learn if BLKR201 is safe in healthy adults. Researchers will also learn how the body absorbs and processes BLKR201 and how food may affect it. The main questions this study aims to answer are: * Is BLKR201 safe and well tolerated when taken as a single dose or for several days in a row? * How does BLKR201 move through and leave the body? * Does taking BLKR201 with food change how the body absorbs it? Researchers will compare BLKR201 to a placebo (a look-alike tablet that contains no drug) in most parts of the study to see how the drug affects participants. Participants will: * Take BLKR201 or a placebo by mouth * Stay at a clinical research unit for several days during dosing * Give blood and urine samples * Have heart tests, vital signs, and lab tests * Report any side effects In one part of the study, a small group of participants will receive BLKR201 only (no placebo). These participants will also have a sample of spinal fluid collected to measure how much BLKR201 reaches the fluid around the brain and spinal cord.

Вмешательства

Препарат BLKR201
BLKR201 is administered orally as a single ascending dose in the SAD stage. In the food effect cohort, BLKR201 is administered under both fasted and fed conditions in separate periods.
Препарат BLKR201
BLKR201 is administered orally once daily for 7 consecutive days in the MAD stage. A twice-daily schedule may be evaluated in a separate cohort if supported by emerging data.
Препарат BLKR201
BLKR201 is administered orally once daily for 7 consecutive days in the CSF cohort. Dosing frequency may be adjusted based on PK findings.
Препарат Placebo
A matching placebo tablet administered orally, corresponding to the dose level and dosing condition of BLKR201 in each assigned cohort.

Первичные конечные точки

Number of Participants with Treatment-Emergent Adverse Events (TEAEs) [Срок оценки: Baseline through approximately 7 days after final dose]
Change From Baseline in Clinical Laboratory Parameters [Срок оценки: Baseline through approximately 7 days after final dose]
Change From Baseline in Systolic Blood Pressure [Срок оценки: Baseline through approximately 7 days after final dose]
Change From Baseline in Diastolic Blood Pressure [Срок оценки: Baseline through approximately 7 days after final dose]
Change From Baseline in Pulse Rate [Срок оценки: Baseline through approximately 7 days after final dose]
Change From Baseline in Respiratory Rate [Срок оценки: Baseline through approximately 7 days after final dose]
Change From Baseline in Body Temperature [Срок оценки: Baseline through approximately 7 days after final dose]
Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters [Срок оценки: Baseline through approximately 7 days after final dose]

Вторичные конечные точки (8)

Maximum Observed Plasma Concentration (Cmax) of BLKR201 After Single Oral Dose [Срок оценки: From predose through approximately 7 days after final dose]
Area Under the Plasma Concentration-Time Curve (AUC) of BLKR201 After Single Oral Dose [Срок оценки: From predose through approximately 7 days after final dose]
Maximum Observed Plasma Concentration (Cmax) After Multiple Doses [Срок оценки: From predose through approximately 7 days after final dose]
Area Under the Plasma Concentration-Time Curve Over the Dosing Interval (AUCtau) After Multiple Doses [Срок оценки: From predose through approximately 7 days after final dose]
BLKR201 Concentration in Cerebrospinal Fluid (CSF) [Срок оценки: Day 7 post-dose in the CSF cohort (single CSF sampling time point per participant)]
Amount of BLKR201 Excreted in Urine [Срок оценки: From predose through 48 hours post-dose (in certain SAD cohorts only)]
Ratio of Maximum Observed Plasma Concentration (Cmax) of BLKR201 Under Fed Versus Fasted Conditions [Срок оценки: From predose through 48 hours post-dose (in certain SAD cohorts only)]
Ratio of Area Under the Plasma Concentration Versus Time Curve (AUC) of BLKR201 Under Fed Versus Fasted Conditions [Срок оценки: From predose through 48 hours post-dose (in certain SAD cohorts only)]

Критерии участия

Критерии включения

Are a healthy man or woman 18 to 55 years old
Weigh at least 50 kilograms (110 pounds)
Have a body mass index (BMI) between 18 and 30
Are willing to stay at the research unit for the required study visits
Are willing to follow study rules about diet, alcohol, tobacco, and medications
Are able to understand and sign the informed consent form

Women who can become pregnant must:

Have a negative pregnancy test before starting
Use a highly effective form of birth control during the study and for a period after the last dose

Men with partners who can become pregnant must:

Use highly effective birth control during the study and for a period after the last dose
Not donate sperm during that time

Критерии исключения

Have any significant medical condition involving the heart, lungs, liver, kidneys, stomach, intestines, brain, blood, or immune system
Have abnormal laboratory test results at screening that the study doctor considers important
Have a history of heart rhythm problems or abnormal electrocardiogram (ECG) results
Have high blood pressure at screening
Have had a serious infection within the past 6 months
Test positive for HIV, hepatitis B, hepatitis C, or tuberculosis
Have a history of cancer in the past 5 years (with limited exceptions for certain treated skin cancers)
Have a history of serious stomach problems such as ulcers, stomach surgery, or stomach bleeding
Use tobacco, nicotine, or marijuana products
Test positive for drugs or alcohol at screening
Have taken another investigational drug within the required time before this study
Have received a live vaccine within 30 days before study start
Are pregnant or breastfeeding
Have a known allergy to the study drug or similar medicines

Additional exclusions:

Regular heavy alcohol use
Regular use of certain medications such as anti-inflammatory drugs, steroids, or blood thinners
Donation of more than 500 milliliters (about one pint) of blood within 1 month before screening

For the spinal fluid (CSF) portion of the study, you cannot take part if you: