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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
72 Years
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
Number of participants with adverse events following single and multiple administration of BBT001 — Parts A and D - Up to Day 141; Parts B, C, and E - Up to Day 169 post first dose administration Incidence, relatedness, and severity of adverse events graded per NCI CTCAE v5.0.
Number of participants with change in serum blood parameters — Parts A and D - Up to Day 141; Parts B, C, and E - Up to Day 169 post first dose administration Laboratory assessments include hematology, blood chemistry and coagulation test
Number of participants with change in vital sign measurements following treatment administration. — Parts A and D - Up to Day 141; Parts B, C, and E - Up to Day 169 post first dose administration Blood pressure and heart rate will be assessed.
Number of participants with change in physical examination following treatment administration. — Parts A and D - Up to Day 141; Parts B, C, and E - Up to Day 169 post first dose administration Physical examination will be assessed.
Number of participants with change in 12-lead ECG readings — Parts A and D - Up to Day 141; Parts B, C, and E - Up to Day 169 post first dose administration 12-lead ECG will be assessed.
Trial sites (14)
Facility
City
Region
Status
First OC Dermatology
Irvine
California
Recruiting
OptiSkin Medical
New York
New York
Recruiting
Equity Medical, LLC
The Bronx
New York
Recruiting
Fremantle Dermatology
Fremantle
Western Australia
Not Yet Recruiting
Linear Clinical Research
Perth
Western Australia
Completed
Optimal Clinical Trials Central Auckland
Grafton
Auckland
Recruiting
Aotearoa Clinical Trials
Otahuhu
Auckland
Withdrawn
Pacific Clinical Research Network (PCRN) - Auckland
Takapuna
Auckland
Recruiting
Optimal Clinical Trials Ltd - Christchurch
Christchurch
New Zealand
Recruiting
Pacific Clinical Research Network (PCRN) Wellington
Upper Hutt
New Zealand
Recruiting
Wojewódzki Specjalistyczny Szpital im. Dr. Wł. Biegańskiego w Łodzi
Lodz
Poland
Recruiting
Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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