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

Korábbi kezelés

• Positive drug/alcohol tests or abnormal vital signs at screening or Day -1.
• Atopic dermatitis with ocular symptoms or chronic ocular steroid use.
• Current use of sedating antihistamines or corticosteroids.

Más betegség

• 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.
• History of drug/alcohol abuse in the past 2 years.
• History of severe allergic reactions or hypersensitivity.
• Skin diseases other than atopic dermatitis, significant tattoos, or scarring.
• Chronic pruritus from conditions other than atopic dermatitis.
• Acute/treated infections or chronic skin infections.

Laborértékek

• Clinically relevant abnormal lab results, including low blood counts, liver issues, or abnormal kidney function.

Egyéb

• Abnormal Electrocardiogram (ECG) findings
• Donated >500mL blood within 2 months of screening.
• Receipt of immunoglobulin or blood products within 30 days.

• 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.
• 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.