Atopic Dermatitis study: BBT001
Official title A Study of BBT001 in Healthy Volunteers (HVs) and in Adult Patients With Atopic Dermatitis (AD)
ClinicalTrials.gov ID: NCT06808477
What this study is testing
What is BBT001?
BBT001 is an investigational medicine being studied as a potential treatment for atopic dermatitis.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to learn how safe and well‑tolerated BBT001 is, and how the body processes it, in healthy people and adults with moderate to severe atopic dermatitis.
- Who it's for
- Healthy volunteers and adult patients who have moderate to severe atopic dermatitis.
- What's involved
- Participants are randomly assigned, without knowing which they get, to receive single or multiple increasing doses of BBT001 or a placebo, with monitoring and tests at the clinic.
- Time commitment
- The trial involves several weeks of dosing and follow‑up visits, with multiple clinic appointments for assessments.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 72. Healthy volunteers may be eligible.
You may be able to join if
- Key 1. 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). Key (Parts A, B, and D)
- Age of 18-65 years.
You likely can't join if
- Significant health issues, such as: diabetes, positive tests for human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B surface...
- History of major metabolic, dermatological, liver, kidney, hematological, or other significant disorders.
- Clinically relevant abnormal lab results, including low blood counts, liver issues, or abnormal kidney function.
- Positive drug/alcohol tests or abnormal vital signs at screening or Day -1.
- Abnormal Electrocardiogram (ECG) findings
- History of drug/alcohol abuse in the past 2 years.
See the full eligibility criteria
- Key 1. 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). Key (Parts A, B, and D)
- 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. Key (Parts C and E only)
- 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. Key
- 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 major metabolic, dermatological, liver, kidney, hematological, or other significant disorders.
- Clinically relevant abnormal lab results, including low blood counts, liver issues, or abnormal kidney function.
- Positive drug/alcohol tests or abnormal vital signs at screening or Day -1.
- Abnormal Electrocardiogram (ECG) findings
- History of drug/alcohol abuse in the past 2 years.
- Donated \>500mL blood within 2 months of screening.
- History of severe allergic reactions or hypersensitivity. Key Exclusion Criteria (Parts A, B, and D only) 1\. History of atopic dermatitis Key Exclusion Criteria (Parts C and E only)
- Skin diseases other than atopic dermatitis, significant tattoos, or scarring.
- Receipt of immunoglobulin or blood products within 30 days.
- Atopic dermatitis with ocular symptoms or chronic ocular steroid use.
- Chronic pruritus from conditions other than atopic dermatitis.
- Acute/treated infections or chronic skin infections.
- Current use of sedating antihistamines or corticosteroids.
The study team makes the final eligibility decision.
Where it is enrolling
- Irvine, California, United States
- New York, New York, United States
- The Bronx, New York, United States
- Fremantle, Western Australia, Australia
- Grafton, Auckland, New Zealand
- Takapuna, Auckland, New Zealand
- Christchurch, New Zealand
- Upper Hutt, New Zealand
- Lodz, Poland
- Rzeszów, Poland
- Warsaw, Poland
- Wroclaw, Poland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 72 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Irvine, California, United States; New York, New York, United States; The Bronx, New York, United States; Fremantle, Western Australia, Australia; Grafton, Auckland, New Zealand; Takapuna, Auckland, New Zealand and 6 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.