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Clinical Trial NCT06808477 for Atopic Dermatitis is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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A Study of BBT001 in Healthy Volunteers (HVs) and in Adult Patients With Atopic Dermatitis (AD) Phase 1 198 Randomized Placebo-Controlled
Clinical Trial NCT06808477 is designed to study Treatment for Atopic Dermatitis. It is a Phase 1 interventional study that is recruiting, having started on 27 February 2025, with plans to enroll 198 participants. Led by Bambusa Therapeutics, it is expected to complete by 6 February 2027. The latest data from ClinicalTrials.gov was last updated on 17 November 2025.
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
The study consists of five parts:
- Part A (single dose of IV administration in HVs in sequential ascending dose cohorts, SAD IV in HVs part)
- Part B (3 repeat doses of IV administration in HVs in sequential ascending dose cohorts, multiple ascending dose (MAD) IV in HVs part)
- Part C (3 repeat doses in participants with moderate to severe AD, MAD IV in patients part)
- Part D (single dose of SC administration in ...
Official Title
A Randomized, Blinded, Placebo-controlled, Single- and Multiple-ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics and Clinical Activity of BBT001 in HVs and AD Patients
Conditions
Atopic DermatitisOther Study IDs
- BBT001-001
NCT ID Number
Start Date (Actual)
2025-02-27
Last Update Posted
2025-11-17
Completion Date (Estimated)
2027-02-06
Enrollment (Estimated)
198
Study Type
Interventional
PHASE
Phase 1
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Triple
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalPart A Single Ascending Dose BBT001 IV A single dose of BBT001 will be administered in healthy volunteers | BBT001 BBT001 will be administered |
ExperimentalPart B Multiple Ascending Dose BBT001 IV Three doses of BBT001 will be administered in healthy volunteers. | BBT001 BBT001 will be administered |
ExperimentalPart C Multiple Ascending Dose BBT001 IV Three doses of BBT001 will be administered in patients with atopic dermatitis. | BBT001 BBT001 will be administered |
Placebo ComparatorPart A Single Ascending Dose Placebo IV A single dose of Placebo will be administered in healthy volunteers | Placebo Placebo will be administered |
Placebo ComparatorPart B Multiple Ascending Dose Placebo IV Three doses of Placebo will be administered in healthy volunteers. | Placebo Placebo will be administered |
Placebo ComparatorPart C Multiple Ascending Dose Placebo IV Three doses of Placebo will be administered in patients with atopic dermatitis. | Placebo Placebo will be administered |
Active ComparatorPart D Single Ascending Dose BBT001 SC A single dose of BBT001 will be administered in healthy volunteers | BBT001 BBT001 will be administered |
Placebo ComparatorPart D Single Ascending Dose Placebo SC A single dose of placebo will be administered in healthy volunteers | Placebo Placebo will be administered |
Active ComparatorPart E Multiple Ascending Dose BBT001 SC - Dose Level 1 Four doses of BBT001 will be administered in patients with atopic dermatitis. | BBT001 BBT001 will be administered |
Placebo ComparatorPart E Multiple Ascending Dose Placebo SC Four doses of placebo will be administered in patients with atopic dermatitis. | Placebo Placebo will be administered |
Active ComparatorPart E Multiple Ascending Dose BBT001 SC - Dose Level 2 Four doses of BBT001 will be administered in patients with atopic dermatitis. | BBT001 BBT001 will be administered |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Number of participants with adverse events following single and multiple administration of BBT001 | Incidence, relatedness, and severity of adverse events graded per NCI CTCAE v5.0. | Part A and D - Up to Day 141; Part B, C and E - Up to Day 169 post first dose administration |
Number of participants with change in serum blood parameters | Laboratory assessments include hematology, blood chemistry and coagulation test | Part A and D - Up to Day 141; Part B, C and E - Up to Day 169 post first dose administration |
Number of participants with change in vital sign measurements following treatment administration. | Blood pressure and heart rate will be assessed. | Part A and D - Up to Day 141; Part B, C and E - Up to Day 169 post first dose administration |
Number of participants with change in physical examination following treatment administration. | Physical examination will be assessed. | Part A and D - Up to Day 141; Part B, C and E - Up to Day 169 post first dose administration |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Pharmacokinetics parameters- maximum observed Concentration (Cmax) | Maximum observed concentration of the study drug in serum will be analyzed for all subjects | At specified timepoints pre-dose and up to 169 days post first dose administration |
Pharmacokinetics parameters- Time for maximum observed Concentration (Tmax) | Serum PK Tmax will be analyzed for all subjects | At specified timepoints pre-dose and up to 169 days post first dose administration |
Pharmacokinetics parameters- Area under the curve (AUC) | Area under the curve of the study drug in serum will be analyzed for all subjects | At specified timepoints pre-dose and up to 169 days post first dose administration |
Pharmacokinetics parameters- Volume of distribution (Vz) | Volume of distribution of the study drug in serum will be analyzed for all subjects | At specified timepoints pre-dose and up to 169 days post first dose administration |
Pharmacokinetics parameters- Total clearance (CL) | Total clearance of the study drug in serum will be analyzed for all subjects | At specified timepoints pre-dose and up to 169 days post first dose administration |
Pharmacokinetics parameters- - Elimination Half-life (t1/2). | Elimination half-life of the study drug in serum will be analyzed for all subjects | At specified timepoints pre-dose and up to 169 days post first dose administration |
The immunogenicity of BBT001 is measured as the number and percentage of subjects who develop Anti-Drug Antibodies (ADA). | Serum Anti-Drug Antibodies will be analyzed for all subjects | At specified timepoints pre-dose and up to 169 days post first dose administration |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
- Age of 18-65 years.
- Body mass index between 18-32 kg/m², capped at 120 kg.
- Negative pregnancy tests for women of childbearing potential.
- Willingness to refrain from alcohol consumption for 24 hours prior to each study visit.
- Non-smokers, healthy current smokers (≤5 cigarettes/day), or ex-smokers.
- Adequate contraception use (for men and women of childbearing potential).
- No clinically significant abnormalities or history of relevant diseases.
Key Inclusion Criteria (Parts C and E only)
- Must have dermatologist-confirmed chronic atopic dermatitis (≥12 months). Inadequate response to topical treatments or where they are medically inadvisable.
- Moderate to severe atopic dermatitis
- Validated investigator's global assessment for atopic dermatitis (vIGA-ADTM) score ≥3
- Atopic lesions cover ≥10% of body surface area (BSA)
- Average peak pruritus numeric rating scale (PP-NRS) score ≥4 in the 7 days before randomization.
- 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.
- History of major metabolic, dermatological, liver, kidney, hematological, or other significant disorders.
- Clinically relevant abnormal lab results, including low blood counts, liver issues, or abnormal kidney function.
- Positive drug/alcohol tests or abnormal vital signs at screening or Day -1.
- Abnormal Electrocardiogram (ECG) findings
- History of drug/alcohol abuse in the past 2 years.
- Donated >500mL blood within 2 months of screening.
- History of severe allergic reactions or hypersensitivity.
Key Exclusion Criteria for (Parts C and E only)
- Skin diseases other than atopic dermatitis, significant tattoos, or scarring.
- Receipt of immunoglobulin or blood products within 30 days.
- Atopic dermatitis with ocular symptoms or chronic ocular steroid use.
- Chronic pruritus from conditions other than atopic dermatitis.
- Acute/treated infections or chronic skin infections.
- Current use of sedating antihistamines or corticosteroids.
Bambusa TherapeuticsStudy Central Contact
Contact: Lisa Li, +1 858 353 4948, [email protected]
7 Study Locations in 3 Countries
Western Australia
Linear Clinical Research, Perth, Western Australia, 6009, Australia
Peter Schrader, Dr, Contact
Recruiting
Auckland
Optimal Clinical Trials Central Auckland, Grafton, Auckland, 1010, New Zealand
Arna Letica, Contact
Recruiting
Aotearoa Clinical Trials, Otahuhu, Auckland, 2025, New Zealand
Cheng Huang, Contact
Recruiting
Pacific Clinical Research Network (PCRN) - Auckland, Takapuna, Auckland, 0622, New Zealand
Paul Hamilton, Contact
Recruiting
Christchurch
Optimal Clinical Trials Ltd - Christchurch, Christchurch Central City, Christchurch, New Zealand
Not yet recruiting
Pacific Clinical Research Network (PCRN) Wellington, Upper Hutt, 5018, New Zealand
Tim Humphrey, Contact
Recruiting
New York
Equity Medical, LLC, The Bronx, New York, 10455, United States
Not yet recruiting