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NCT06808477 | RECRUITING | Atopic Dermatitis

A Study of BBT001 in Healthy Volunteers (HVs) and in Adult Patients With Atopic Dermatitis (AD)
Sponsor:

Bambusa Therapeutics

Brief Summary:

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).

Condition or disease

Atopic Dermatitis

Intervention/treatment

BBT001

Placebo

Phase

PHASE1

Detailed Description:

The study consists of five parts: * Part A (single dose of IV administration in HVs in sequential ascending dose cohorts, SAD IV in HVs part) * Part B (3 repeat doses of IV administration in HVs in sequential ascending dose cohorts, multiple ascending dose (MAD) IV in HVs part) * Part C (3 repeat doses in participants with moderate to severe AD, MAD IV in patients part) * Part D (single dose of SC administration in HVs in sequential ascending dose cohorts, SAD SC in HVs part) * Part E (4 repeat doses in participants with moderate to severe AD, MAD SC in patients part)

Study Type : INTERVENTIONAL
Estimated Enrollment : 198 participants
Masking : TRIPLE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2025-02-27
Estimated Primary Completion Date : 2026-08-21
Estimated Study Completion Date : 2027-02-06

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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.
    • A Study of BBT001 in Healthy Volunteers (HVs) and in Adult Patients With Atopic Dermatitis (AD)

    Location Details

    NCT06808477

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    How to Participate

    Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

    Locations

    NOT YET RECRUITING

    United States, New York

    Equity Medical, LLC

    The Bronx, New York, United States, 10455

    RECRUITING

    Australia, Western Australia

    Linear Clinical Research

    Perth, Western Australia, Australia, 6009

    RECRUITING

    New Zealand, Auckland

    Optimal Clinical Trials Central Auckland

    Grafton, Auckland, New Zealand, 1010

    RECRUITING

    New Zealand, Auckland

    Aotearoa Clinical Trials

    Otahuhu, Auckland, New Zealand, 2025

    RECRUITING

    New Zealand, Auckland

    Pacific Clinical Research Network (PCRN) - Auckland

    Takapuna, Auckland, New Zealand, 0622

    NOT YET RECRUITING

    New Zealand, Christchurch

    Optimal Clinical Trials Ltd - Christchurch

    Christchurch Central City, Christchurch, New Zealand,

    RECRUITING

    New Zealand,

    Pacific Clinical Research Network (PCRN) Wellington

    Upper Hutt, New Zealand, 5018