Testing BBT001 in healthy volunteers and adults with atopic dermatitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 clinical trial evaluates the safety and efficacy of BBT001 through a randomized, blinded, placebo-controlled design. The study is divided into three parts: Part A involves healthy volunteers receiving a single ascending dose, Part B involves healthy volunteers receiving multiple ascending doses, and Part C focuses on adult patients with moderate to severe atopic dermatitis receiving multiple doses. The aim is to assess the drug's effects and safety profile in both healthy individuals and those with the target condition.

Why it matters

Who can join: the full rules

Key Inclusion Criteria

1. Negative pregnancy tests for women of childbearing potential.
2. Willingness to refrain from alcohol consumption for 24 hours prior to each study visit.
3. Non-smokers, healthy current smokers (≤5 cigarettes/day), or ex-smokers.
4. Adequate contraception use (for men and women of childbearing potential).

Key Inclusion Criteria (Parts A, B, and D)

1. Age of 18-65 years.
2. Body mass index of 18 to 32 kg/m², weight capped at 120 kg.
3. No clinically significant abnormalities or history of relevant diseases.

Key Inclusion Criteria (Parts C and E only)

1. Age of 18-72 years.
2. Body mass index ≥16 kg/m², weight capped at 125 kg.
3. Must have dermatologist-confirmed chronic atopic dermatitis (≥12 months). Inadequate response to topical treatments or where they are medically inadvisable.
4. Moderate to severe atopic dermatitis
5. Validated investigator's global assessment for atopic dermatitis (vIGA-ADTM) score ≥3
6. Atopic lesions cover ≥10% of body surface area (BSA)
7. Average peak pruritus numeric rating scale (PP-NRS) score ≥4 in the 7 days before randomization.

Key Exclusion Criteria

1. 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.
2. History of major metabolic, dermatological, liver, kidney, hematological, or other significant disorders.
3. Clinically relevant abnormal lab results, including low blood counts, liver issues, or abnormal kidney function.
4. Positive drug/alcohol tests or abnormal vital signs at screening or Day -1.
5. Abnormal Electrocardiogram (ECG) findings
6. History of drug/alcohol abuse in the past 2 years.
7. Donated \>500mL blood within 2 months of screening.
8. 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)

1. Skin diseases other than atopic dermatitis, significant tattoos, or scarring.
2. Receipt of immunoglobulin or blood products within 30 days.
3. Atopic dermatitis with ocular symptoms or chronic ocular steroid use.
4. Chronic pruritus from conditions other than atopic dermatitis.
5. Acute/treated infections or chronic skin infections.
6. Current use of sedating antihistamines or corticosteroids.

Where it's running

• First OC Dermatology
  Irvine, California, United States Recruiting
• OptiSkin Medical
  New York, New York, United States Recruiting
• Equity Medical, LLC
  The Bronx, New York, United States Recruiting
• Fremantle Dermatology
  Fremantle, Western Australia, Australia Recruiting
• Optimal Clinical Trials Central Auckland
  Grafton, Auckland, New Zealand Recruiting
• Pacific Clinical Research Network (PCRN) - Auckland
  Takapuna, Auckland, New Zealand Recruiting

Study contacts

• Study coordinator: Lisa Li
• Email: Lisa.Li@bambusatx.com
• Phone: +1 617-848-6188

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Roflumilast Cream 0.3% for moderate to severe atopic dermatitis in children, adolescents, and adults

  A cream called roflumilast 0.3% is tested once daily to see if it helps people with moderate to severe atopic dermatitis, compared to a non-medicated cream, across ages 6 and up.

  Recruiting at 4 sites Phase 3 Arcutis Biotherapeutics, Inc. · Birmingham, Alabama and 3 other locations · NCT07916480

• Nocturnal ScratchSense ring: test of automatic scratch detection in adults with itchy skin

  This study tests whether the Replior ScratchSense ring can accurately detect and measure nighttime scratching in adults with itchy skin conditions.

  Recruiting Replior AB · Grenoble · NCT07909967

• ADBest TREAT Registry for adults with atopic dermatitis

  A registry in Germany is collecting real-world data from adults with atopic dermatitis to see how treatments are used and how the disease affects quality of life.

  Recruiting Universitätsklinikum Hamburg-Eppendorf · Hamburg · NCT07904546

• How lebrikizumab affects the skin microbiome and mycobiome in adults with atopic dermatitis

  This study looks at whether lebrikizumab changes the skin bacteria, fungi, and specifically Staphylococcus species, in adults with moderate-to-severe atopic dermatitis.

  Recruiting University Hospital Bispebjerg and Frederiksberg · Copenhagen · NCT07807228

• QX-4533 safety study in healthy volunteers and people with moderate-to-severe atopic dermatitis

  This study tests the safety and tolerability of QX-4533, given as a pill, in healthy adults and in patients with moderate-to-severe atopic dermatitis to see how the drug behaves in the body and what side effects may occur.

  Recruiting Phase 1 QuantX Biosciences US Inc. · Shanghai, Shanghai Municipality · NCT07800104

• Tilrekimig for moderate-to-severe eczema in teens and adults

  A 52-week study will test tilrekimig against dupilumab and a placebo to see if it helps people 12 and older with moderate-to-severe atopic dermatitis.

  Recruiting at 31 sites Phase 3 Pfizer · Birmingham, Alabama and 49 other locations · NCT07783425

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.