This is a Phase 1, randomized, blinded, placebo controlled, single ascending dose (SAD) study of BBT001 in healthy volunteers (HVs) and adult patients with moderate to severe Atopic Dermatitis (AD).
Age of 18-65 years.
Body mass index between 18-28 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.
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.
Sequential
BBT001
DrugBBT001 will be administered
Placebo
DrugPlacebo 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.
Number of participants with change in vital sign measurements following treatment administration.
Blood pressure and heart rate will be assessed.
Number of participants with change in serum blood parameters.
Laboratory assessments include hematology, blood chemistry and coagulation test
Number of participants with change in physical examination following treatment administration.
Physical examination will be assessed.
Pharmacokinetics parameters- maximum observed Concentration (Cmax)
Maximum observed concentration of the study drug in serum will be analyzed for all subjects.
Pharmacokinetics parameters- Time for maximum observed Concentration (Tmax)
Serum PK Tmax will be analyzed for all subjects
Pharmacokinetics parameters- Area under the curve (AUC)
Area under the curve of the study drug in serum will be analyzed for all subjects
Pharmacokinetics parameters- Volume of distribution (Vz)
Volume of distribution of the study drug in serum will be analyzed for all subjects
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