NCT06808477RecruitingPhase 1
A Study of BBT001 in Healthy Volunteers (HVs) and in Adult Patients With Atopic Dermatitis (AD)
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
Source: ClinicalTrials.gov · Last updated 29 Sept 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 237 (estimated)
- First submitted
- 30 Jan 2025
- Start date
- 27 Feb 2025
- Primary completion date
- 28 Feb 2027
- Lead sponsor
- Bambusa Therapeutics
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT06808477
- EU CT number
- 2025-522918-23-00
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 237
- From 27 Feb 2025 to the primary completion date, 28 Feb 2027
- 14 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
- 1\. 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.
Lab values
- Clinically relevant abnormal lab results, including low blood counts, liver issues, or abnormal kidney function.
Other
- Abnormal Electrocardiogram (ECG) findings
- Donated \>500mL blood within 2 months of screening.
- Receipt of immunoglobulin or blood products within 30 days.
Who the study is looking for
- 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.
Age in the registry: 18 years to 72 years · Sex: All · Accepts healthy volunteers
Sites (14)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fremantle Dermatology Coordinator of this site? Confirm its status | Fremantle | Australia | Recruiting |
| Linear Clinical Research Coordinator of this site? Confirm its status | Perth | Australia | Completed |
| Optimal Clinical Trials Ltd - Christchurch Coordinator of this site? Confirm its status | Christchurch | New Zealand | Recruiting |
| Optimal Clinical Trials Central Auckland Coordinator of this site? Confirm its status | Grafton | New Zealand | Recruiting |
| Aotearoa Clinical Trials Coordinator of this site? Confirm its status | Otahuhu | New Zealand | Withdrawn |
| Pacific Clinical Research Network (PCRN) - Auckland Coordinator of this site? Confirm its status | Takapuna | New Zealand | Recruiting |
| Pacific Clinical Research Network (PCRN), Wellington Coordinator of this site? Confirm its status | Upper Hutt | New Zealand | Recruiting |
| Wojewodzki Specjalistyczny Szpital Im Dr Wl Bieganskiego Coordinator of this site? Confirm its status | Lodz | Poland | Recruiting |
| Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie Coordinator of this site? Confirm its status | Rzeszów | Poland | Recruiting |
| Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Cityclinic Przychodnia lekarsko psychologiczna Matusiak sp.p Coordinator of this site? Confirm its status | Wroclaw | Poland | Recruiting |
| First OC Dermatology Coordinator of this site? Confirm its status | Irvine | United States | Recruiting |
| OptiSkin Medical Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Equity Medical, LLC Coordinator of this site? Confirm its status | The Bronx | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.