A Study to Learn About the Safety of BIIB142 and How it is Processed in the Body of Healthy Adult Participants Aged 18 to 55 Years Old

Официальное название

A Phase 1, Randomized, Blinded, Placebo-Controlled, Single- and Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB142 in Healthy Adults

Обзор

In this study, researchers will learn more about the safety of BIIB142 and how it is processed in the body. This is the first time that researchers will learn about BIIB142 and how it affects people. The main question researchers want to answer in this study is: • How many participants have adverse events (AEs) and serious adverse events (SAEs)? An AE is a health problem that may or may not be caused by a drug during the study. An AE is considered serious when it results in death, is life-threatening, causes lasting problems, or requires hospital care. Researchers will also learn more about: • How the body processes BIIB142 This is a "dose escalation study." This is a study in which increasing amounts of the study drug are given to different groups of participants. This is done until researchers find the highest dose that does not cause harmful effects. First, participants will be screened to check if they can join the study. The screening period will be up to 28 days. This study will be split into 2 parts - Part A and Part B. During Part A: * Participants will be randomly placed into 1 of 6 groups to receive a single dose of either BIIB142 or a placebo. A placebo looks like the study drug but contains no real medicine. * Participants in Groups 1 through 5 will take either BIIB142 or the placebo without food. Participants in Group 6 will take 2 doses of their assigned treatment - once with food and once without food. * Neither the researchers nor the participants will know if the participants will receive BIIB142 or the placebo. * Participants will stay at their study research center for 5 days. They will return for another 4 visits. Each participant in Part A will be in the study for up to 58 days. During Part B: * Participants will be randomly placed into 1 of 3 groups to receive BIIB142 or the placebo. In Part B, participants will take BIIB142 or the placebo once a day for 14 days. * Neither the researchers nor the participants will know if the participants will receive BIIB142 or the placebo. * Participants will stay at their study research center for 16 days. They will return for another 4 visits. Each participant in Part B will be in the study for up to 58 days.

Подробное описание

The primary objective of this study is to evaluate the safety and tolerability of single and multiple ascending oral doses of BIIB142 in healthy adult participants.

The secondary objective of this study is to evaluate the pharmacokinetics (PK) profile of single and multiple ascending oral doses of BIIB142 in healthy adult participants.

Вмешательства

• Препарат BIIB142
  Administered Orally
• Препарат BIIB142-Matching Placebo
  Administered Orally

Первичные конечные точки

• Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Срок оценки: Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29]
• Number of Participants with Clinical Laboratory Abnormalities [Срок оценки: Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29]
• Number of Participants with Potentially Clinically Relevant Abnormalities in Vital Sign Parameters [Срок оценки: Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29]
• Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Score [Срок оценки: Part B (MAD): Up to Day 29]
• Number of Participants With Potentially Clinically Relevant Abnormalities in 12-lead Electrocardiogram (ECG) Parameters [Срок оценки: Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29]

Вторичные конечные точки (7)

• Plasma Concentration of BIIB142 [Срок оценки: Pre-dose and at multiple timepoints post-dose [Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29]]
• Area Under the Concentration-Time Curve (AUC) of BIIB142 [Срок оценки: Pre-dose and at multiple timepoints post-dose [Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29]]
• Maximum Observed Concentration (Cmax) of BIIB142 [Срок оценки: Pre-dose and at multiple timepoints post-dose [Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29]]
• Time to Maximum Observed Concentration (Tmax) of BIIB142 [Срок оценки: Pre-dose and at multiple timepoints post-dose [Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29]]
• Apparent Clearance (CL/F) of BIIB142 [Срок оценки: Pre-dose and at multiple timepoints post-dose [Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29]]
• Apparent Volume of Distribution (Vz/F) of BIIB142 [Срок оценки: Pre-dose and at multiple timepoints post-dose [Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29]]
• Elimination Half-Life (t1/2) of BIIB142 [Срок оценки: Pre-dose and at multiple timepoints post-dose [Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29]]

Критерии участия

Критерии включения

• Have a body mass index between 18 and 32 kilograms per square meter (kg/m\^2), inclusive, at screening.
• Weight ≥ 50 kilograms (kg) at screening.
• Negative polymerase chain reaction (PCR) test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at Check-in prior to randomization.
• Must be in good health as determined by the Investigator.

Критерии исключения

• History of any clinically significant cardiac, endocrine, gastrointestinal, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the Investigator.
• History of severe allergic or anaphylactic reactions
• History of or ongoing malignant disease (with limited exceptions)
• Systolic blood pressure >150 millimeters of mercury (mmHg) or <90 mmHg.
• Clinically significant (as determined by the Investigator) electrocardiogram (ECG) abnormalities.
• History of or positive test for human immunodeficiency virus (HIV).
• Chronic, recurrent, or serious infection within 90 days prior to Screening.
• Symptoms of bacterial, fungal, or viral infection within 14 days prior to Screening.
• Any live or attenuated immunization within 14 days prior to Screening.
• Use of prescription medications, over-the-counter medications that alter hepatic or renal clearance, or nutraceuticals within 28 days prior to Check-in.
• MAD Cohorts only: Suicidal ideation with some intent to act within 6 months prior to the start of Screening or history of suicidal behavior within one year prior to Screening.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• PPD Development, LP — Las Vegas

Идентификаторы

NCT: NCT07133828 · 300HV101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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