A Study of BBT002 in Healthy Volunteers (HVs) and in Adult Patients With Chronic Obstructive Pulmonary Disease (COPD) or Chronic Rhiosininusitis With Nasal Polyps (CRSwNP)

Официальное название

A Randomized, Double-Blind, Placebo-controlled, Single- and Multiple-ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics and Clinical Activity of BBT002 in Healthy Volunteers and Patients With COPD or CRSwNP

Обзор

Randomized study of single and multiple doses of BBT002 in healthy volunteers and in adult patients with chronic obstructive pulmonary disease (COPD) or chronic rhinosinusitis with nasal polyps (CRSwNP).

Подробное описание

This study a is a randomized, double-blinded, placebo-controlled single (SAD) and multiple-ascending dose (MAD) study to evaluate safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics, and exploratory clinical activity of BBT002 in healthy volunteers (HVs) and in adult patients with COPD or CRSwNP. BBT002 is a drug candidate being developed for the treatment of COPD or CRSwNP. BBT002 will be given by intravenous injection or subcutaneous injection.

Вмешательства

• Препарат BBT002
  BBT002 will be administered.
• Препарат Placebo
  Placebo will be administered.

Первичные конечные точки

• Number of participants with adverse events following single and multiple administration of BBT002 [Срок оценки: Parts A and E - up to 141 days post first dose administration; Parts B, C, D, F, and G - up to 169 days post first dose administration]
• Number of participants with change in Laboratory assessments [Срок оценки: Parts A and E - up to 141 days post first dose administration; Parts B, C, D, F, and G - up to 169 days post first dose administration]
• Number of participants with change in vital sign measurements following dose administration. [Срок оценки: Parts A and E - up to 141 days post first dose administration; Parts B, C, D, F, and G - up to 169 days post first dose administration]
• Number of participants with change in physical examination following dose administration. [Срок оценки: Parts A and E - up to 141 days post first dose administration; Parts B, C, D, F, and G - up to 169 days post first dose administration]
• Number of participants with change in 12-lead ECG readings [Срок оценки: Parts A and E - up to 141 days post first dose administration; Parts B, C, D, F, and G - up to 169 days post first dose administration]

Вторичные конечные точки (7)

• PK parameters- maximum observed concentration (Cmax) [Срок оценки: At specified timepoints pre-dose and up to 169 days post first dose administration]
• PK parameters- Time of maximum observed Concentration (Tmax) [Срок оценки: At specified timepoints pre-dose and up to 169 days post first dose administration]
• PK parameters- Area under the curve (AUC) [Срок оценки: At specified timepoints pre-dose and up to 169 days post first dose administration]
• PK parameters- Volume of distribution (Vz) [Срок оценки: At specified timepoints pre-dose and up to 169 days post first dose administration]
• PK parameters- Total clearance (CL) [Срок оценки: At specified timepoints pre-dose and up to 169 days post first dose administration]
• PK parameters- - Elimination Half-life (t1/2). [Срок оценки: At specified timepoints pre-dose and up to 169 days post first dose administration]
• The immunogenicity of BBT002 is measured as the number and percentage of subjects who develop Anti-Drug Antibodies (ADA). [Срок оценки: At specified timepoints pre-dose and up to 169 days post first dose administration]

Критерии участия

Key Inclusion Criteria (Parts A, B, C, D, E, F, and G)

• Age 18-65 years for HVs (Parts A, B, and E); age 35-80 years for patients with COPD (Parts C and F,); age 18-80 for patients with CRSwNP (Parts D and G)
• Body mass index between 18.0-32.0 kg/m square, capped weight at 120kg, for HVs (Parts A, B, and E); body mass index between 16.0-35.0 kg/m square, capped weight at 125kg for patients (Parts C, D, F, and G)
• Negative pregnancy tests for women of childbearing potential
• Willingness to refrain from alcohol consumption for 24 hours prior to each study visit
• Non-smokers, healthy current smokers (≤5 cigarettes/day), or ex-smokers
• Adequate contraception use (for men and women of childbearing potential)
• No clinically significant abnormalities or history of relevant diseases

Key Inclusion Criteria (Part C and F only) 1. Documented history of COPD with a post-bronchodilator Forced Expiratory Volume in 1 second/Forced Vital Capacity less than 0.70

Key Inclusion Criteria (Parts D and G)

1\. Participants with confirmed diagnosis of CRSwNP

Key Exclusion Criteria for (Parts A, B, C, D, E, F, and G)

• Positive viral serology for human immunodeficiency virus (HlV), hepatitis C virus (HCV), or hepatitis B (HBV)
• Immunodeficiencies, autoimmune diseases, or cancer, history of conditions predisposing to infections
• History of major metabolic, dermatological, liver, kidney, hematological or other significant disorders
• Clinically relevant abnormal lab results, including low blood counts, liver enzymes, or abnormal kidney function
• Positive drug/alcohol tests or abnormal vital signs at screening or Day -1
• Abnormal Electrocardiogram(ECG) findings
• History of drug/alcohol abuse in the past 2 years
• History of severe allergic reactions or hypersensitivity

Key Exclusion Criteria (Part C and F only)

• Current diagnosis of other significant pulmonary disease
• Significant or unstable cardiovascular diseases
• Recent clinically significant infection
• Inability to perform spirometry

Key Exclusion Criteria (Parts D and G)

• Steroid refractoriness: Refractory to systemic corticosteriods for CRSwNP
• Sinonasal surgery (recent/extensiv)
• Consitions interfering with nasal assessments
• Excluded sinonasal/systemic diseases

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Грузия · 4 центра

• Aleksandre Aladashvili Clinic LLC — Tbilisi
• Geo Hospitals Tbilisi Multiprofile Medical Center — Tbilisi
• LEPL The First University Clinic of Tbilisi State Medical University — Tbilisi
• Ltd Aversi Clinic — Tbilisi

США · 3 центра

• Equity Medical Bowling Green — Bowling Green
• Equity Medical - Owensboro — Owensboro
• Equity Medical LLC — New York

Новая Зеландия · 3 центра

• Momentum Clinical Research Hamilton — Rotorua
• Momentum Clinical Research — Pukekohe
• Momentum Clinical Research — Wellington

Австралия · 2 центра

• Linear Clinical Research — Perth
• Momentum Clinical Research — Brisbane

Польша · 2 центра

• Uniwersyteckie Centrum Kliniczne Osrodka Badan Klinicznych Wczesnych Faz — Gdansk
• Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o. — Krakow

Идентификаторы

NCT: NCT06944925 · BBT002-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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