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

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 Adult Patients With AD

Обзор

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

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 BBT001 in healthy volunteers (HVs) and in adult patients with atopic dermatitis. BBT001 is a drug candidate being developed for the treatment of atopic dermatitis.

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: Parts A and D - Up to Day 141; Parts B, C, and E - Up to Day 169 post first dose administration]
• Number of participants with change in serum blood parameters [Срок оценки: Parts A and D - Up to Day 141; Parts B, C, and E - Up to Day 169 post first dose administration]
• Number of participants with change in vital sign measurements following treatment administration. [Срок оценки: Parts A and D - Up to Day 141; Parts B, C, and E - Up to Day 169 post first dose administration]
• Number of participants with change in physical examination following treatment administration. [Срок оценки: Parts A and D - Up to Day 141; Parts B, C, and E - Up to Day 169 post first dose administration]
• Number of participants with change in 12-lead ECG readings [Срок оценки: Parts A and D - Up to Day 141; Parts B, C, and E - 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

Критерии включения

• 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).

Key Inclusion Criteria (Parts A, B, and D)

• Age of 18-65 years.
• Body mass index of 18 to 32 kg/m², weight capped at 120 kg.
• No clinically significant abnormalities or history of relevant diseases.

Key Inclusion Criteria (Parts C and E only)

• Age of 18-72 years.
• Body mass index ≥16 kg/m², weight capped at 125 kg.
• 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.

Критерии исключения

• 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 (Parts A, B, and D only)

1\. History of atopic dermatitis

Key Exclusion Criteria (Parts C and E only)

• Skin diseases other than atopic dermatitis, significant tattoos, or scarring.
• Receipt of immunoglobulin or blood products within 30 days.
• Atopic dermatitis with ocular symptoms or chronic ocular steroid use.
• Chronic pruritus from conditions other than atopic dermatitis.
• Acute/treated infections or chronic skin infections.
• Current use of sedating antihistamines or corticosteroids.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Новая Зеландия · 5 центров

• Optimal Clinical Trials Central Auckland — Grafton
• Aotearoa Clinical Trials — Otahuhu
• Pacific Clinical Research Network (PCRN) - Auckland — Takapuna
• Optimal Clinical Trials Ltd - Christchurch — Christchurch
• Pacific Clinical Research Network (PCRN) Wellington — Upper Hutt

Польша · 4 центра

• Wojewódzki Specjalistyczny Szpital im. Dr. Wł. Biegańskiego w Łodzi — Lodz
• Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie — Rzeszów
• Państwowy Instytut Medyczny MSWiA — Warsaw
• Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska — Wroclaw

США · 3 центра

• First OC Dermatology — Irvine
• OptiSkin Medical — New York
• Equity Medical, LLC — The Bronx

Австралия · 2 центра

• Fremantle Dermatology — Fremantle
• Linear Clinical Research — Perth

Идентификаторы

NCT: NCT06808477 · BBT001-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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