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

Launched by BAMBUSA THERAPEUTICS · Jan 30, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called BBT001 for people with atopic dermatitis, which is a skin condition that causes itchy, inflamed skin. The trial is in the early phase of testing, where researchers are looking to see how safe the treatment is and how well it works in both healthy volunteers and adults with moderate to severe atopic dermatitis. They are currently recruiting participants aged 18 to 65 who either don't have any significant health issues or have chronic atopic dermatitis that hasn't responded well to other treatments.

If you or someone you know is considering participating, you'll need to meet certain criteria, such as being within the specified age range and having a body weight that falls within a healthy range. Participants will need to avoid alcohol for 24 hours before visits and cannot smoke more than five cigarettes a day. Those with atopic dermatitis will need to show that their condition is moderate to severe. Throughout the study, participants will receive either the new treatment or a placebo (a treatment with no active ingredients) to compare results. It’s important to understand that this trial aims to gather valuable information about this new treatment, which could help improve care for people with atopic dermatitis in the future.

Gender

ALL

Eligibility criteria

• • Key Inclusion Criteria (Part A, B, C)
• • 1. Age of 18-65 years.
• • 2. Body mass index between 18-32 kg/m², capped at 120 kg.
• • 3. Negative pregnancy tests for women of childbearing potential.
• • 4. Willingness to refrain from alcohol consumption for 24 hours prior to each study visit.
• • 5. Non-smokers, healthy current smokers (≤5 cigarettes/day), or ex-smokers.
• • 6. Adequate contraception use (for men and women of childbearing potential).
• • 7. No clinically significant abnormalities or history of relevant diseases.
• • Key Inclusion Criteria (Part C only)
• • 1. Must have dermatologist-confirmed chronic atopic dermatitis (≥12 months). Inadequate response to topical treatments or where they are medically inadvisable.
• • 2. Moderate to severe atopic dermatitis
• • 3. Validated investigator's global assessment for atopic dermatitis (vIGA-ADTM) score ≥3
• • 4. Atopic lesions cover ≥10% of body surface area (BSA)
• • 5. Average peak pruritus numeric rating scale (PP-NRS) score ≥4 in the 7 days before randomization.
• • Key Exclusion Criteria for (Part A, B, C)
• • 1. 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.
• • 2. History of major metabolic, dermatological, liver, kidney, hematological, or other significant disorders.
• • 3. Clinically relevant abnormal lab results, including low blood counts, liver issues, or abnormal kidney function.
• • 4. Positive drug/alcohol tests or abnormal vital signs at screening or Day -1.
• • 5. Abnormal Electrocardiogram (ECG) findings
• • 6. History of drug/alcohol abuse in the past 2 years.
• • 7. Donated \>500mL blood within 2 months of screening.
• • 8. History of severe allergic reactions or hypersensitivity.
• • Key Exclusion Criteria for (Part C only)
• • 1. Skin diseases other than atopic dermatitis, significant tattoos, or scarring.
• • 2. Receipt of immunoglobulin or blood products within 30 days.
• • 3. Atopic dermatitis with ocular symptoms or chronic ocular steroid use.
• • 4. Chronic pruritus from conditions other than atopic dermatitis.
• • 5. Acute/treated infections or chronic skin infections.
• • 6. Current use of sedating antihistamines or corticosteroids.