A Study of BBT001 in Healthy Volunteers (HVs) and in Adult Patients With Atopic Dermatitis (AD)
Purpose
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).
Condition
- Atopic Dermatitis
Eligibility
- Eligible Ages
- Between 18 Years and 72 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Part A Single Ascending Dose BBT001 |
A single dose of BBT001 will be administered in healthy volunteers |
|
|
Experimental Part B Multiple Ascending Dose BBT001 |
Multiple doses of BBT001 will be administered in healthy volunteers. |
|
|
Experimental Part C Multiple Ascending Dose BBT001 |
Multiple doses of BBT001 will be administered in patients with atopic dermatitis. |
|
|
Placebo Comparator Part A Single Ascending Dose Placebo |
A single dose of Placebo will be administered in healthy volunteers |
|
|
Placebo Comparator Part B Multiple Ascending Dose Placebo |
Multiple doses of Placebo will be administered in healthy volunteers. |
|
|
Placebo Comparator Part C Multiple Ascending Dose Placebo |
Multiple doses of Placebo will be administered in patients with atopic dermatitis. |
|
|
Active Comparator Part D Single Ascending Dose BBT001 |
A single dose of BBT001 will be administered in healthy volunteers |
|
|
Placebo Comparator Part D Single Ascending Dose Placebo |
A single dose of placebo will be administered in healthy volunteers |
|
|
Active Comparator Part E Multiple Ascending Dose BBT001 - Dose Level 1 |
Multiple doses of BBT001 will be administered in patients with atopic dermatitis. |
|
|
Placebo Comparator Part E Multiple Ascending Dose Placebo |
Multiple doses of placebo will be administered in patients with atopic dermatitis. |
|
|
Active Comparator Part E Multiple Ascending Dose BBT001 - Dose Level 2 |
Multiple doses of BBT001 will be administered in patients with atopic dermatitis |
|
Recruiting Locations
OptiSkin Medical
New York, New York 10128
New York, New York 10128
Equity Medical, LLC
The Bronx, New York 10455
The Bronx, New York 10455
More Details
- Status
- Recruiting
- Sponsor
- Bambusa Therapeutics
Detailed Description
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.