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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
237
First OC Dermatology
Irvine, California, United States
RECRUITINGOptiSkin Medical
New York, New York, United States
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
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Equity Medical, LLC
The Bronx, New York, United States
RECRUITINGFremantle Dermatology
Fremantle, Western Australia, Australia
NOT_YET_RECRUITINGLinear Clinical Research
Perth, Western Australia, Australia
COMPLETEDOptimal Clinical Trials Central Auckland
Grafton, Auckland, New Zealand
RECRUITINGAotearoa Clinical Trials
Otahuhu, Auckland, New Zealand
WITHDRAWNPacific Clinical Research Network (PCRN) - Auckland
Takapuna, Auckland, New Zealand
RECRUITINGOptimal Clinical Trials Ltd - Christchurch
Christchurch, New Zealand
RECRUITINGPacific Clinical Research Network (PCRN) Wellington
Upper Hutt, New Zealand
RECRUITING...and 4 more locations
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