A Phase 1 Study of S-4321

Официальное название

A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Single and Multiple Ascending Dose Trial of S-4321 in Healthy Volunteers

Обзор

This is the first-in-human study of S-4321 designed to provide safety, tolerability, pharmacokinetic, and pharmacodynamic data in healthy volunteers.

Подробное описание

This is a randomized, placebo-controlled, double-blind, study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics of S-4321 administered to healthy adult participants. This study will be conducted in two parts, Part 1 (single ascending dose, SAD) and Part 2 (multiple ascending doses, MAD).

Вмешательства

• Препарат S-4321
  S-4321 via subcutaneous or intravenous administration
• Другое Placebo
  Placebo via subcutaneous or intravenous administration.

Первичные конечные точки

• Number of participants with treatment-related adverse and serious adverse events as assessed by CTCAE v5.0 [Срок оценки: 2 months]

Вторичные конечные точки (9)

• To assess the maximum serum concentration (CMAX) [Срок оценки: 2 months]
• To assess time to reach maximum serum concentration (tMAX) [Срок оценки: 2 months]
• To assess elimination half-life (t1/2) [Срок оценки: 2 months]
• To assess area under the serum concentration-time curve from time 0 to t hours (AUC0-t) and to infinity (AUC0-inf) [Срок оценки: 2 months]
• To assess clearance (CL) [Срок оценки: 2 months]
• To assess volume of distribution (Vz) and steady-state volume of distribution (Vss) [Срок оценки: 2 months]
• To assess bioavailability after SC administration (F%) [Срок оценки: 2 months]
• To characterize absolute change from baseline of Receptor Occupancy (RO) at multiple timepoints [Срок оценки: 2 months]
• Incidence and characterization of anti-drug antibody (ADA) [Срок оценки: 2 months]

Критерии участия

Критерии включения

• Is available for the entire duration of the study and follow up.
• Is willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.
• Voluntarily consents to participation in the trial as documented by signing the study informed consent form (ICF).
• Has a body mass index (BMI) within 18 to 32 kg/m2, inclusive, and weighs ≥45 kg.
• Is in good physical and mental health in the opinion of the Investigator or delegate.

Major Exclusion Criteria:

• Has a history of severe allergic or anaphylactic reaction as determined by the Investigator or delegate.
• Is pregnant, nursing, or is planning to become pregnant or breastfeed during the trial.
• Has a known immunodeficiency disorder.
• Has a history of malignancy or confirmed cervical dysplasia.
• Has a history of human immunodeficiency virus (HIV) or positive serology for HIV at Screening.
• Has positive laboratory evidence for active hepatitis at screening.
• Has any other condition or prior therapy that, in the opinion of the Investigator or delegate, may potentially compromise the safety or compliance of the participant, or may preclude the participant from successfully completing the study.

Other inclusion/exclusion eligibility criteria 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

Австралия · 1 центр

• Veritus Research — Bayswater

Идентификаторы

NCT: NCT06877611 · S-4321-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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