Study of BW-50218 in Healthy Participants

Официальное название

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered BW-50218 in Healthy Participants

Обзор

Phase 1, Single Ascending Dose Study of Subcutaneous BW-50218 in Healthy Participants

Подробное описание

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered BW-50218 in Healthy Participants

Вмешательства

• Препарат BW-50218 Injection
  Solution for injection
• Препарат Saline (0.9% NaCl)
  Solution for injection

Первичные конечные точки

• Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Срок оценки: From baseline up to Day 360 (End of Study)]
• Change from Baseline in Clinical Laboratory Test Results [Срок оценки: From baseline up to Day 360 (End of Study)]
• Change from Baseline in Vital Signs [Срок оценки: From baseline up to Day 360 (End of Study)]
• Change from Baseline in 12-Lead Electrocardiogram (ECG) Parameters [Срок оценки: From baseline up to Day 360 (End of Study)]
• Change from Baseline in Physical Examination Findings [Срок оценки: From baseline up to Day 360 (End of Study)]

Вторичные конечные точки (6)

• Maximum Observed Plasma Concentration (Cmax) [Срок оценки: From pre-dose up to Day 8]
• Time to Maximum Plasma Concentration (Tmax) [Срок оценки: From pre-dose up to Day 8]
• Area Under the Plasma Concentration-Time Curve (AUC) [Срок оценки: From pre-dose up to Day 8]
• Terminal Elimination Half-Life (t1/2) [Срок оценки: From pre-dose up to Day 8]
• Urine Pharmacokinetic Parameters [Срок оценки: From pre-dose up to 24 hours post-dose]
• Change from Baseline in Serum Transthyretin (TTR) Protein Concentration [Срок оценки: From baseline up to Day 360 (End of Study)]

Критерии участия

Критерии включения

• Capable of providing written informed consent and complying with all study procedures for the duration of the study.
• Body weight and body mass index (BMI) within a range considered appropriate for study participation by the investigator.
• Female participants must be non-pregnant, non-lactating, and either of non-childbearing potential or using highly effective contraception.
• Male participants with partners of childbearing potential must agree to use effective contraception.

Критерии исключения

• Any medical condition, recent illness, or laboratory result that, in the investigator's opinion, may increase risk or interfere with participation in the study.
• Recent hospitalization or a significant acute medical event.
• History of cancer or any long-term medical condition that the study doctor considers clinically relevant.
• Clinical laboratory findings outside of range which are deemed clinically significant by the investigator at screening or Day -1.
• Positive test for hepatitis B, hepatitis C, or HIV.

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 · 2 центра

• CMAX Clinical Research Pty Ltd — Adelaide
• Linear Early Fhase Limited — Nedlands

Идентификаторы

NCT: NCT07401472 · BW-50218-1001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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