Atopic Dermatitis
Conditions
Brief summary
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).
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.
Interventions
DRUGBBT001
BBT001 will be administered
DRUGPlacebo
Placebo will be administered
Sponsors
Bambusa Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 72 Years
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics parameters - maximum observed Concentration (Cmax) | At specified timepoints pre-dose and up to 169 days post first dose administration | Maximum observed concentration of the study drug in serum will be analyzed for all subjects |
| Pharmacokinetics parameters - Time for maximum observed Concentration (Tmax) | At specified timepoints pre-dose and up to 169 days post first dose administration | Serum PK Tmax will be analyzed for all subjects |
| Pharmacokinetics parameters - Area under the curve (AUC) | At specified timepoints pre-dose and up to 169 days post first dose administration | Area under the curve of the study drug in serum will be analyzed for all subjects |
| Pharmacokinetics parameters - Volume of distribution (Vz) | At specified timepoints pre-dose and up to 169 days post first dose administration | Volume of distribution of the study drug in serum will be analyzed for all subjects |
| Pharmacokinetics parameters - Total clearance (CL) | At specified timepoints pre-dose and up to 169 days post first dose administration | Total clearance of the study drug in serum will be analyzed for all subjects |
| Pharmacokinetics parameters - Elimination Half-life (t1/2). | At specified timepoints pre-dose and up to 169 days post first dose administration | Elimination half-life of the study drug in serum will be analyzed for all subjects |
| The immunogenicity of BBT001 is measured as the number and percentage of subjects who develop Anti-Drug Antibodies (ADA). | At specified timepoints pre-dose and up to 169 days post first dose administration | Serum Anti-Drug Antibodies will be analyzed for all subjects |
Countries
Australia, New Zealand, Poland, United States
Contacts
CONTACTLisa Li
STUDY_DIRECTORLisa Li
Bambusa Therapeutics, Inc.
Outcome results
None listed