Study of S-892216 Long-acting Injectable (LAI) in Healthy Adult Participants

Официальное название

Phase 1 Study of a Long-acting Injectable S-892216 in Healthy Adult Participants

Обзор

The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics (PK) of single- and multiple-dose administration of S-892216-LAI in healthy adults.

Вмешательства

• Препарат S-892216-LAI
  S-892216-LAI injection will be administered per schedule specified in the arm description.
• Препарат Placebo
  Physiological saline will be administered per schedule specified in the arm description.

Первичные конечные точки

• Part: Number of Participants With Treatment-emergent Adverse Events (TEAEs) [Срок оценки: Day 1 through Day 364]
• Part 2: Number of Participants With TEAEs [Срок оценки: Day 1 through Day 448]

Вторичные конечные точки (6)

• Part 1: Maximum Plasma Concentration (Cmax) of S-892216 and its Metabolites [Срок оценки: Day 1 (pre-administration, up to 12 hours post-administration) through Day 364]
• Part 2: Cmax of S-892216 and its Metabolites [Срок оценки: Day 1 (pre-administration, up to 12 hours post-administration) through Day 70 in Treatment Period 1 and Day 85 (pre-administration, up to 12 hours post-administration) through Day 448 in Treatment Period 2]
• Part 1: Time to Reach Cmax (Tmax) of S-892216 and its Metabolites [Срок оценки: Day 1 (pre-administration, up to 12 hours post-administration) through Day 364]
• Part 2: Tmax of S-892216 and its Metabolites [Срок оценки: Day 1 (pre-administration, up to 12 hours post-administration) through Day 70 in Treatment Period 1 and Day 85 (pre-administration, up to 12 hours post-administration) through Day 448 in Treatment Period 2]
• Part 1: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration After Dosing (AUC0-last) of S-892216 and its Metabolites [Срок оценки: Day 1 (pre-administration, up to 12 hours post-administration) through Day 364]
• Part 2: AUC0-last of S-892216 and its Metabolites [Срок оценки: Day 1 (pre-administration, up to 12 hours post-administration) through Day 70 in Treatment Period 1 and Day 85 (pre-administration, up to 12 hours post-administration) through Day 448 in Treatment Period 2]

Критерии участия

Критерии включения

• Body mass index (BMI) ≥18.5 and ≤32.0 kilograms (kg)/square meter (m\^2)

Критерии исключения

• Presence or history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, neurological, or ophthalmological (for example, increased intra-ocular pressure) disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data per the investigator's assessment.
• History of cancer except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
• Require medication or other treatment (for example, dietary restrictions or physical therapy).
• Participated in any other clinical study involving an investigational study intervention or any other type of medical research within 30 days, or 5 times the half-life of the investigational drug, before signing of the informed consent form (ICF) for this study or who are currently participating in such a study.
• Positive test results of the following at screening or within 6 months prior to administration of study intervention: hepatitis B surface antigen (HBsAg); hepatitis C virus antibody (HCV); and human immunodeficiency virus (HIV) antigen/antibody.
• Positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) reverse transcription polymerase chain reaction (RT-PCR) test result, positive transcription-mediated amplification test result, positive antigen test result, or any other test approved according to local regulations at check in for each period on admission.
• Known allergy/sensitivity or any hypersensitivity to components of S-892216-LAI or placebo for S-892216-LAI.
• Used cannabis (medical or recreational), tobacco, or nicotine-containing products (including e-cigarettes, pipe tobacco, cigar, chewing tobacco, nicotine patch, and nicotine gum) within 6 months prior to admission.

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

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 2 центра

• ICON Clinical Research: Lenexa — Lenexa
• ICON Clinical Research: Salt Lake City — Salt Lake City

Идентификаторы

NCT: NCT07093580 · 2316T1711

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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