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

RecruitingPhase 1Ages 18 Years - 72 YearsAllBambusa Therapeutics
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In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Key Inclusion Criteria 1. Negative pregnancy tests for women of childbearing potential. 2. Willingness to refrain from alcohol consumption for 24 hours prior to each study visit. 3. Non-smokers, healthy current smokers (≤5 cigarettes/day), or ex-smokers. 4. Adequate contraception use (for men and women of childbearing potential). Key Inclusion Criteria (Parts A, B, and D) 1. Age of 18-65 years. 2. Body mass index of 18 to 32 kg/m², weight capped at 120 kg. 3. No clinically significant abnormalities or history of relevant diseases. Key Inclusion Criteria (Parts C and E only) 1. Age of 18-72 years. 2. Body mass index ≥16 kg/m², weight capped at 125 kg. 3. Must have dermatologist-confirmed chronic atopic dermatitis (≥12 months). Inadequate response to topical treatments or where they are medically inadvisable. 4. Moderate to severe atopic dermatitis 5. Validated investigator's global assessment for atopic dermatitis (vIGA-ADTM) score ≥3 6. Atopic lesions cover ≥10% of body surface area (BSA) 7. Average peak pruritus numeric rating scale (PP-NRS) score ≥4 in the 7 days before randomization. Key Exclusion Criteria 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 (Parts A, B, and D only) 1\. History of atopic dermatitis Key Exclusion Criteria (Parts C and E 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.
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What it tests

  • BBT001
  • Placebo
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Where

14 sites
First OC Dermatology
Irvine, United States
OptiSkin Medical
New York, United States
Equity Medical, LLC
The Bronx, United States
Fremantle Dermatology
Fremantle, Australia
Linear Clinical Research
Perth, Australia
Optimal Clinical Trials Central Auckland
Grafton, New Zealand
Aotearoa Clinical Trials
Otahuhu, New Zealand
Pacific Clinical Research Network (PCRN) - Auckland
Takapuna, New Zealand

…and 6 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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