A Study of BBT002 in Healthy Volunteers (HVs) and in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) With or Without Comorbid Asthma

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 Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) With or Without Comorbid Asthma

Обзор

This study is 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 Participants with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) with or without Asthma.

Подробное описание

The study consists of two parts:

* Part A (single dose in HVs in sequential ascending dose cohorts, SAD in HVs part) * Part B (five repeated doses in patients with CRSwNP, MAD in patients part)

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: Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration]
• Number of participants with change in vital sign measurements following dose administration. [Срок оценки: Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration]
• Number of participants with change in physical examination following dose administration. [Срок оценки: Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration]
• Number of participants with change in Laboratory assessments [Срок оценки: Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration]
• Number of participants with change in 12-lead ECG readings [Срок оценки: Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration]

Вторичные конечные точки (7)

• 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- maximum observed concentration (Cmax) [Срок оценки: At specified timepoints pre-dose and up to 169 days post first dose administration]
• PK parameters- Time for maximum observed Concentration (Tmax) [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

Inclusion Criteria: Part (A\&B):

• Age of 18-55 years (HVs), 18-75 years (patients)
• Body mass index between 18-30 kg/m², capped at 120 kg
• 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

Key Inclusion Criteria (Part B only)

• Participants with physician-diagnosed CRSwNP before screening.
• SNOT-22 total score ≥30 at screening and randomization.
• Documented systemic corticosteroid use (or contraindication/intolerance) within past 24 months.
• Diagnosed asthma per GINA 2025, stable for ≥12 months. Stable on GINA Step 3 or higher therapy for 6 weeks before screening.
• For the participants have comorbid asthma, they had to be stable using their regular asthma treatment.

Exclusion Criteria:Part (A\&B):

• 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 for (Part B only):

• Any sinus/nasal surgery (including polypectomy) within 6 months before screening, History of >2 prior sinus/nasal surgeries
• Concurrent nasal conditions that may interfere with study assessments
• Significant or unstable cardiovascular diseases
• Recent clinically significant infection

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 12 центров

• People's Hospital of Peking University — Пекин
• The Third Affiliated Hospital of Sun Yat-sen University — Гуанчжоу
• Xiangya Hospital of Central South University — Чанша
• Jiangsu Province Hospital — Нанкин
• The Second Hospital of Shandong Province — Цзинань
• Qingdao University Hospital — Qingdao
• The Affiliated Yuhuangding Hospital of Qingdao University — Yantai
• Zibo Hospital of Shandong University — Zibo
• … и ещё 4 центра

Идентификаторы

NCT: NCT07436949 · BBT002-003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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