A Study of BBT001 in Healthy Volunteers (HVs) and in Adult Patients With Atopic Dermatitis (AD)
ConditionAtopic Dermatitis
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-72
SponsorBambusa Therapeutics
About this trial
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).
Eligibility criteria
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- BBT001
- Placebo
Treatment groups
237 Participants
are divided into 11 treatment groups11
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov