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Набира участници Фаза 1 NCT06944925

A Study of BBT002 in Healthy Volunteers (HVs) and in Adult Patients With Chronic Obstructive Pulmonary Disease (COPD)

Фаза 1 – тестване на безопасността при малка група хора
Заболявания: Chronic Obstructive Pulmonary Disease

Спонсор: Bambusa Therapeutics

Налично на: БГ
Обобщение
This study is a randomized, blinded, placebo-controlled single (SAD) and multiple ascending dose (MAD) study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics and exploratory clinical activity of BBT002 in healthy volunteers (HVs) and in adult patients with Chronic Obstructive Pulmonary Disease (COPD).
Описание
The study consists of three parts: * Part A (single dose in HVs in sequential ascending dose cohorts, SAD in HVs part) * Part B (three repeated doses in HVs in sequential ascending dose cohorts, MAD in HVs part) * Part C (two repeated doses in patients with COPD, MAD in patients part)
Кой може да участва
Key Inclusion Criteria (Parts A, B, C) 1. Age of 18-65 years (HVs), 35-75 years (patients) 2. Body mass index between 18-32 kg/m², capped at 120 kg 3. Negative pregnancy tests for women of childbearing potential 4. Willingness to refrain from alcohol consumption for 24 hours prior to each study visit 5. Non-smokers, healthy current smokers (≤5 cigarettes/day), or ex-smokers 6. Adequate contraception use (for men and women of childbearing potential) 7. No clinically significant abnormalities or history of relevant diseases Key Inclusion Criteria (Part C only) 1. Documented history of COPD with a post-bronchodilator FEV1/FVC \< 0.70 2. FEV1 ≥ 30% and FEV1\<80% predicted at screening. Key Exclusion Criteria for (Parts A, B, C) 1. Positive viral serology for human immunodeficiency virus (HlV), hepatitis C virus (HCV), or hepatitis B (HBV) 2. Immunodeficiencies, autoimmune diseases, or cancer, history of conditions predisposing to infections 3. History of major metabolic, dermatological, liver, kidney, hematological or other significant disorders 4. Clinically relevant abnormal lab results, including low blood counts, liver enzymes, or abnormal kidney function 5. Positive drug/alcohol tests or abnormal vital signs at screening or Day -1 6. Abnormal Electrocardiogram(ECG) findings 7. History of drug/alcohol abuse in the past 2 years 8. History of severe allergic reactions or hypersensitivity Key Exclusion Criteria for (Part C only) 1. Current diagnosis of other significant pulmonary disease 2. Significant or unstable cardiovascular diseases 3. Recent clinically significant infection 4. Inability to perform spirometry
Места на провеждане 1
Австралия (1)
Linear Clinical Research
Perth , Western Australia
Технически детайли
Статус
Набира участници
Фаза
Фаза 1
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
75 Years
Здрави доброволци
Не
Начална дата
08.05.2025
Крайна дата
31.03.2027
Регистрационен номер
NCT06944925
Източник
anzctr
Запитване за медицински туризъм

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