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
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for healthy adult volunteers and adults with moderate to severe atopic dermatitis to test BBT001 against placebo.
- Age
- Healthy volunteer parts: 18-65 years. Atopic dermatitis parts: 18-72 years.
- Sex
- Men and women can join.
- Disease stage
- Atopic dermatitis parts: chronic atopic dermatitis for at least 12 months, confirmed by a dermatologist, moderate to severe, with a vIGA-AD score of 3 or more. Lesions cover at least 10% of body surface area. Average peak itch score is 4 or more in the 7 days before randomization.
- Earlier treatment
- Atopic dermatitis parts: topical treatments did not work well enough, or are medically inadvisable. Cannot currently use sedating antihistamines or corticosteroids. Cannot have had immunoglobulin or blood products in the last 30 days.
Main reasons for not taking part
- Significant health problems such as diabetes, positive HIV, hepatitis C or hepatitis B surface antigen tests, immunodeficiency, autoimmune disease or cancer
- History of atopic dermatitis (healthy volunteer parts only)
- Skin diseases other than atopic dermatitis, significant tattoos or scarring (atopic dermatitis parts)
- Drug or alcohol abuse in the past 2 years
- Abnormal ECG or clinically relevant abnormal lab results
Read by machine on 9 November 2026.
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.