Идёт набор NCT07288554

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

Фаза I С лечением Chronic Obstructive Pulmonary Disease (COPD)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: BBT002, Placebo.
Кому может быть актуально: Состояния в реестре: Chronic Obstructive Pulmonary Disease (COPD). Базовые параметры: 18 лет — 75 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Китай
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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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 Obstructive Pulmonary Disease (COPD)

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 Obstructive Pulmonary Disease (COPD).

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 (two repeated doses in patients with COPD, 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 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 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 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- 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- 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

Inclusion Criteria:( A\&B)

Age of 18-65 years (HVs), 35-75 years (patients)
Body mass index between 18-32 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
Adequate contraception use (for men and women of childbearing potential)
No clinically significant abnormalities or history of relevant diseases

Key Inclusion Criteria (Part B only)

Documented history of COPD with a post-bronchodilator FEV1/FVC < 0.70
FEV1 ≥ 30% and FEV1<80% predicted at screening.

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)