Идёт набор NCT07239947

A Study of BBT001 in Healthy Volunteers (HVs) and in Adult Patients With Moderate to Severe Atopic Dermatitis (AD)

Фаза I С лечением Atopic Dermatitis

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: BBT001, Placebo.
Кому может быть актуально: Состояния в реестре: Atopic Dermatitis. Базовые параметры: 18 лет — 65 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, Blinded, Placebo-controlled, Single- and Multiple-ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics and Clinical Activity of BBT001 in HVs and AD Patient

Обзор

This is a Phase 1, randomized, blinded, placebo controlled, single ascending dose (SAD) study of BBT001 in healthy volunteers (HVs) and adult patients with moderate to severe Atopic Dermatitis (AD).

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 (seven repeated doses in patients with moderate to severe AD, multiple ascending Dose in patients part)

Вмешательства

Препарат BBT001
BBT001 will be administered
Препарат Placebo
Placebo will be administered

Первичные конечные точки

Number of participants with adverse events following single and multiple administration of BBT001 [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 treatment 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 serum blood parameters. [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 treatment 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 electrocardiogram (ECG) results measurements following treatment administration. [Срок оценки: Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration]

Вторичные конечные точки (7)

Pharmacokinetics parameters- maximum observed Concentration (Cmax) [Срок оценки: At specified timepoints pre-dose and up to 169 days post first dose administration.]
Pharmacokinetics parameters- Time for maximum observed Concentration (Tmax) [Срок оценки: At specified timepoints pre-dose and up to 169 days post first dose administration]
Pharmacokinetics parameters- Area under the curve (AUC) [Срок оценки: At specified timepoints pre-dose and up to 169 days post first dose administration]
Pharmacokinetics parameters- Volume of distribution (Vz) [Срок оценки: At specified timepoints pre-dose and up to 169 days post first dose administration]
Pharmacokinetics parameters- Total clearance (CL) [Срок оценки: At specified timepoints pre-dose and up to 169 days post first dose administration]
Pharmacokinetics 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 BBT001 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 ( Part A and B):

Age of 18-65 years.
Body mass index between 18-28 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):

Must have dermatologist-confirmed chronic atopic dermatitis (≥12 months). Inadequate response to topical treatments or where they are medically inadvisable.
Moderate to severe atopic dermatitis
Validated investigator's global assessment for atopic dermatitis (vIGA-ADTM) score ≥3
Atopic lesions cover ≥10% of body surface area (BSA)
Average peak pruritus numeric rating scale (PP-NRS) score ≥4 in the 7 days before randomization.
Eczema Area and Severity Index (EASI) score ≥16 at screening and randomization visits.
（for biologic/JAKi experienced subjects) Patients with prior systemic exposure to the following agents are eligible for enrollment: biologics targeting IL-4/IL-13 or IL-31 pathway or JAK inhibitors.

Key Exclusion Criteria for (Part A\&B)

Significant health issues, such as: diabetes, positive tests for human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B surface antigen (HBsAg), 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 issues, 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.
Donated >500mL blood within 2 months of screening.
History of severe allergic reactions or hypersensitivity.

Key Exclusion Criteria for (Part B only)