A Phase 1 interventional study of BBT001 and Placebo in Atopic Dermatitis, sponsored by Bambusa Therapeutics. Recruiting at 14 sites in 4 countries. Open to participants aged 18 Years to 72 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Bambusa Therapeutics · Phase 1, Interventional, and Treatment
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).
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.
Key Inclusion Criteria
Key Inclusion Criteria (Parts A, B, and D)
Key Inclusion Criteria (Parts C and E only)
Key Exclusion Criteria
Key Exclusion Criteria (Parts A, B, and D only)
1. History of atopic dermatitis
Key Exclusion Criteria (Parts C and E only)
A single dose of BBT001 will be administered in healthy volunteers
Drug: BBT001
Multiple doses of BBT001 will be administered in healthy volunteers.
Drug: BBT001
Multiple doses of BBT001 will be administered in patients with atopic dermatitis.
Drug: BBT001
A single dose of Placebo will be administered in healthy volunteers
Drug: Placebo
Multiple doses of Placebo will be administered in healthy volunteers.
Drug: Placebo
Multiple doses of Placebo will be administered in patients with atopic dermatitis.
Drug: Placebo
A single dose of BBT001 will be administered in healthy volunteers
Drug: BBT001
A single dose of placebo will be administered in healthy volunteers
Drug: Placebo
Multiple doses of BBT001 will be administered in patients with atopic dermatitis.
Drug: BBT001
Multiple doses of placebo will be administered in patients with atopic dermatitis.
Drug: Placebo
Multiple doses of BBT001 will be administered in patients with atopic dermatitis
Drug: BBT001
BBT001 will be administered
Placebo will be administered
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.
Time frame: Parts A and D - Up to Day 141; Parts 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
Time frame: Parts A and D - Up to Day 141; Parts 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.
Time frame: Parts A and D - Up to Day 141; Parts 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.
Time frame: Parts A and D - Up to Day 141; Parts B, C, and E - Up to Day 169 post first dose administration
Number of participants with change in 12-lead ECG readings
12-lead ECG will be assessed.
Time frame: Parts A and D - Up to Day 141; Parts B, C, and E - Up to Day 169 post first dose administration
Pharmacokinetics parameters - maximum observed Concentration (Cmax)
Maximum observed concentration of the study drug in serum will be analyzed for all subjects
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration
Plan to share: No
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Bambusa Therapeutics