Testing BBT001 in healthy volunteers and adults with atopic dermatitis

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 AD Patients

This study is testing a new drug called BBT001 in healthy people and adults with atopic dermatitis to see if it's safe and effective.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 198 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Bambusa Therapeutics (Industry-sponsored)
• Locations: 7 sites (The Bronx, New York and 6 other locations)
• Trial ID: NCT06808477 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-65 with chronic atopic dermatitis who have not responded adequately to topical treatments.

Not a fit: Patients with mild atopic dermatitis or those who have not been diagnosed with the condition may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a new treatment option for patients suffering from moderate to severe atopic dermatitis.

How similar studies have performed: While this approach is not widely tested, similar studies have shown promise in evaluating new treatments for atopic dermatitis.

Eligibility criteria

Key Inclusion Criteria (Part A, B, C, D)

1. Age of 18-65 years.
2. Body mass index between 18-32 kg/m², capped at 120 kg.
3. Negative pregnancy tests for women of childbearing potential.
4. Willingness to refrain from alcohol consumption for 24 hours prior to each study visit.
5. Non-smokers, healthy current smokers (≤5 cigarettes/day), or ex-smokers.
6. Adequate contraception use (for men and women of childbearing potential).
7. No clinically significant abnormalities or history of relevant diseases.

Key Inclusion Criteria (Parts C and E only)

1. Must have dermatologist-confirmed chronic atopic dermatitis (≥12 months). Inadequate response to topical treatments or where they are medically inadvisable.
2. Moderate to severe atopic dermatitis
3. Validated investigator's global assessment for atopic dermatitis (vIGA-ADTM) score ≥3
4. Atopic lesions cover ≥10% of body surface area (BSA)
5. Average peak pruritus numeric rating scale (PP-NRS) score ≥4 in the 7 days before randomization.

Key Exclusion Criteria for (Part A, B, C, D)

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 for (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 this trial is running

The Bronx, New York and 6 other locations

• Equity Medical, LLC — The Bronx, New York, United States (Not_yet_recruiting)
• Linear Clinical Research — Perth, Western Australia, Australia (Recruiting)
• Optimal Clinical Trials Central Auckland — Grafton, Auckland, New Zealand (Recruiting)
• Aotearoa Clinical Trials — Otahuhu, Auckland, New Zealand (Recruiting)
• Pacific Clinical Research Network (PCRN) - Auckland — Takapuna, Auckland, New Zealand (Recruiting)
• Optimal Clinical Trials Ltd - Christchurch — Christchurch Central City, Christchurch, New Zealand (Not_yet_recruiting)
• Pacific Clinical Research Network (PCRN) Wellington — Upper Hutt, New Zealand (Recruiting)

Study contacts

• Study coordinator: Lisa Li

Conditions Atopic Dermatitis