Tests BBT001 in healthy volunteers and adults with atopic dermatitis
Tests the drug BBT001 against placebo in adults with atopic dermatitis.
Plain-language title generated from the registry record
Registry title: A Study of BBT001 in Healthy Volunteers (HVs) and in Adult Patients With Atopic Dermatitis (AD)
Key facts
- Where
- Lodz, Rzeszów, Warsaw, and Wroclaw, PolandSee the 4 sites
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 72 years old?
Source: NCT06808477, who can take part
Where in Poland
- Wojewodzki Specjalistyczny Szpital Im Dr Wl BieganskiegoLodz, PolandTaking people
- Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W RzeszowieRzeszów, PolandTaking people
- Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i AdministracjiWarsaw, PolandTaking people
- Cityclinic Przychodnia lekarsko psychologiczna Matusiak sp.pWroclaw, PolandTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Bambusa Therapeutics
- Trial code
- NCT06808477EU 2025-522918-23-00
- Record updated
- 29 September 2026
- Original description
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).Read full original descriptionShow less
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
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).
Inclusion: 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.
Exclusion: Positive drug/alcohol tests or abnormal vital signs at screening or Day -1; Atopic dermatitis with ocular symptoms or chronic ocular steroid use; Current use of sedating antihistamines or corticosteroids; 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; History of drug/alcohol abuse in the past 2 years; History of severe allergic reactions or hypersensitivity; History of atopic dermatitis; Skin diseases other than atopic dermatitis, significant tattoos, or scarring; Chronic pruritus from conditions other than atopic dermatitis; Acute/treated infections or chronic skin infections; Clinically relevant abnormal lab results, including low blood counts, liver issues, or abnormal kidney function; Abnormal Electrocardiogram (ECG) findings; Donated >500mL blood within 2 months of screening; Receipt of immunoglobulin or blood products within 30 days.