A Phase 1 Clinical Study 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-41012 in Healthy Participants

Обзор

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered BW-41012 in Healthy Participants

Подробное описание

This is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) study of BW-41012 when administered subcutaneously to healthy participants. Approximately 40 men and women aged ≥18 to ≤65 years (inclusive) who fulfill the inclusion and exclusion criteria will be enrolled in 5 cohorts.

Вмешательства

• Препарат BW-41012 injection or Placebo
  BW-41012 injection or Placebo dosage form is solution for injection and route of administration is subcutaneous injection
• Препарат BW-41012 injection or Placebo
  BW-41012 injection or Placebo dosage form is solution for injection and route of administration is subcutaneous injection
• Препарат BW-41012 injection or Placebo
  BW-41012 injection or Placebo dosage form is solution for injection and route of administration is subcutaneous injection
• Препарат BW-41012 injection or Placebo
  BW-41012 injection or Placebo dosage form is solution for injection and route of administration is subcutaneous injection
• Препарат BW-41012 injection or Placebo
  BW-41012 injection or Placebo dosage form is solution for injection and route of administration is subcutaneous injection

Первичные конечные точки

• Primary endpoints [Срок оценки: up to 24 hours]

Вторичные конечные точки (2)

• Secondary endpoints [Срок оценки: up to 8 days]
• Secondary endpoints [Срок оценки: up to 360days]

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 65 years old, inclusive, at the time of informed consent
• Body mass index (BMI) ≥18.0 and ≤32.0 kg/m2 and body weight ≥50.0 kg.
• APTT, PT, INR, and FXI activity within the normal range at screening
• Agree to avoid activities that can increase the risk of severe bleeding
• 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 360 days following administration of the study drug

Критерии исключения

• Any clinically significant chronic medical condition or clinically significant abnormality in laboratory parameters
• Any skin condition and/or tattoo
• Hospitalization for any reason within 60 days prior to screening
• History or presence of cancer
• 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
• Any liver function panel analyte value > 1.2 × upper limits of normal (ULN)
• Positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody
• Single 12-lead ECG with clinically significant abnormalities at screening or Day -1
• Use of an investigational agent
• .Used of prescription drugs
• History or clinical evidence of alcohol substance abuse
• History or clinical evidence of drug abuse
• Positive test for alcohol or drugs of abuse at screening or Day -1
• Donated or lost >200 mL of blood
• .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

Четверное слепое

Основная цель

Лечение

Центры проведения

Австралия · 1 центр

• Argo Investigative Site — Perth

Идентификаторы

NCT: NCT07584876 · BW-41012-1001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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