A Phase 1 Clinical Study of BW-20805-2-1001 in Healthy Participants

Официальное название

A Phase 1, Open-Label, Single Dose Bridging Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered BW-20805-2 in Healthy Participants

Обзор

A Phase 1 Clinical Study Of BW-20805-2-1001 in Healthy Participants

Подробное описание

A Phase 1, Open-Label, Single Dose Bridging Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered BW-20805-2 in Healthy Participants

Вмешательства

• Препарат BW-20805
  Cohort 1 will receive SC administrations of BW-20805 on Day1.
• Препарат BW-20805
  Group 2 will receive SC administrations of BW-20805 on Day1
• Препарат BW-20805-2
  Group 3 will receive SC administrations of BW-20805-2 on Day1.

Первичные конечные точки

• Primary Endpoints [Срок оценки: week 48]

Вторичные конечные точки (1)

• Secondary Endpoints [Срок оценки: week 48]

Критерии участия

Критерии включения

• Must have given written informed consent and be able to comply with all study requirements
• Males or females aged 18 to 60 years old, inclusive, at the time of informed consent.
• Body mass index (BMI) ≥18 and ≤32 kg/m2 and body weight ≥50 kg Female participants must be non-pregnant
• Male participants with female partners of child-bearing potential must agree to use acceptable methods of contraception from screening until 48 weeks following administration of the study drug

Критерии исключения

• Any clinically significant chronic medical condition or clinically significant abnormality in physical examination that
• Any skin condition and/or tattoo that may interfere with the evaluation of safety at the injection site
• Hospitalization for any reason within 60 days prior to screening.
• Presence of carcinoma and history of carcinoma
• Any clinically significant acute condition
• Systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg after at least 5 minutes resting
• Clinical laboratory findings outside of range are deemed clinically significant by the investigator at screening
• Participants with ANY in clinical laboratory tests at screening or Day-1.
• History of bleeding diathesis or clinically significant hemorrhagic disorders Positive for hepatitis B surface antigen
• Single 12-lead ECG with clinically significant abnormalities at screening or Day -1
• Use of an investigation agent or device within 30 days or 5 half-lives (whichever is longer) before the study drug administration.
• Used prescription drugs, excluding hormonal contraceptives
• Used over-the-counter (OTC) medications
• Have received treatment with small interfering RNA (siRNA) within the last 12 months
• History of allergic reactions to synthetic siRNA or GalNAc and/or any other clinically significant allergic reactions.
• Use of more than 10 tobacco/nicotine containing products or equivalent per day within 30 days prior to screening and not willing to abstain for 48 hours prior to admission to the unit
• History or clinical evidence of alcohol substance abuse, within the 12 months before screening
• History or clinical evidence of drug abuse, within the 12 months before screening
• Positive test for alcohol or drugs of abuse at screening or Day -1
• Have received vaccination with a live vaccine
• Donated or lost >200 mL of blood or plasma within 30 days prior to screening
• Any conditions which, in the opinion of the Investigator

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

Открытое

Основная цель

Лечение

Центры проведения

Австралия · 1 центр

• Argo Investigative Site — Melbourne

Идентификаторы

NCT: NCT07528053 · BW-20805-2-1001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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