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A Study of BBT001 in Healthy Volunteers (HVs) and in Adult Patients With Atopic Dermatitis (AD)
Sponsor: Bambusa Therapeutics
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).
Official title: A Randomized, Blinded, Placebo-controlled, Single- and Multiple-ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics and Clinical Activity of BBT001 in HVs and Adult Patients With AD
Key Details
Gender
All
Age Range
18 Years - 72 Years
Study Type
INTERVENTIONAL
Enrollment
237
Start Date
2025-02-27
Completion Date
2027-02-28
Last Updated
2026-07-09
Healthy Volunteers
Yes
Conditions
Interventions
BBT001
BBT001 will be administered
Placebo
Placebo will be administered
Locations (14)
First OC Dermatology
Irvine, California, United States
OptiSkin Medical
New York, New York, United States
Equity Medical, LLC
The Bronx, New York, United States
Fremantle Dermatology
Fremantle, Western Australia, Australia
Linear Clinical Research
Perth, Western Australia, Australia
Optimal Clinical Trials Central Auckland
Grafton, Auckland, New Zealand
Aotearoa Clinical Trials
Otahuhu, Auckland, New Zealand
Pacific Clinical Research Network (PCRN) - Auckland
Takapuna, Auckland, New Zealand
Optimal Clinical Trials Ltd - Christchurch
Christchurch, Christchurch, New Zealand
Pacific Clinical Research Network (PCRN) Wellington
Upper Hutt, New Zealand
Wojewódzki Specjalistyczny Szpital im. Dr. Wł. Biegańskiego w Łodzi
Lodz, Poland
Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie
Rzeszów, Poland
Państwowy Instytut Medyczny MSWiA
Warsaw, Poland
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska
Wroclaw, Poland