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
Status: Recruiting
Location: See all (14) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 72
Healthy Volunteers: t
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• 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).
• Age of 18-65 years.
• Body mass index of 18 to 32 kg/m², weight capped at 120 kg.
• No clinically significant abnormalities or history of relevant diseases.
• Age of 18-72 years.
• Body mass index ≥16 kg/m², weight capped at 125 kg.
• Must have dermatologist-confirmed chronic atopic dermatitis (≥12 months). Inadequate response to topical treatments or where they are medically inadvisable.
• Moderate to severe atopic dermatitis
• Validated investigator's global assessment for atopic dermatitis (vIGA-ADTM) score ≥3
• Atopic lesions cover ≥10% of body surface area (BSA)
• Average peak pruritus numeric rating scale (PP-NRS) score ≥4 in the 7 days before randomization.
Locations
United States
California
First OC Dermatology
RECRUITING
Irvine
New York
OptiSkin Medical
RECRUITING
New York
Equity Medical, LLC
RECRUITING
The Bronx
Other Locations
Australia
Fremantle Dermatology
NOT_YET_RECRUITING
Fremantle
Linear Clinical Research
COMPLETED
Perth
New Zealand
Optimal Clinical Trials Ltd - Christchurch
RECRUITING
Christchurch
Optimal Clinical Trials Central Auckland
RECRUITING
Grafton
Aotearoa Clinical Trials
WITHDRAWN
Otahuhu
Pacific Clinical Research Network (PCRN) - Auckland
RECRUITING
Takapuna
Pacific Clinical Research Network (PCRN) Wellington
RECRUITING
Upper Hutt
Poland
Wojewódzki Specjalistyczny Szpital im. Dr. Wł. Biegańskiego w Łodzi
RECRUITING
Lodz
Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie