A Study of BBT001 in Healthy Volunteers (HVs) and in Adult Patients With Atopic Dermatitis (AD)
Start Date
2/27/2025
Completion Date
2/28/2027
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
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.
Eligibility Criteria
Age Range: 18 years to 72 years
Interventions
BBT001
Placebo
Conditions
Locations
First OC Dermatology
Irvine, California 92614
United States
OptiSkin Medical
New York, New York 10128
United States
Equity Medical, LLC
The Bronx, New York 10455
United States
Fremantle Dermatology
Fremantle, Western Australia 6160
Australia
Linear Clinical Research
Perth, Western Australia 6009
Australia
Optimal Clinical Trials Central Auckland
Grafton, Auckland 1010
New Zealand
Aotearoa Clinical Trials
Otahuhu, Auckland 2025
New Zealand
Pacific Clinical Research Network (PCRN) - Auckland
Takapuna, Auckland 0622
New Zealand
Optimal Clinical Trials Ltd - Christchurch
Christchurch, Christchurch
New Zealand
Pacific Clinical Research Network (PCRN) Wellington
Upper Hutt, 5018
New Zealand
Wojewódzki Specjalistyczny Szpital im. Dr. Wł. Biegańskiego w Łodzi
Lodz, 91-347
Poland
Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie
Rzeszów, 35-055
Poland
Państwowy Instytut Medyczny MSWiA
Warsaw, 02-507
Poland
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska
Wroclaw, 50-566
Poland