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Recruiting NCT06808477

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

Phase I Interventional Atopic Dermatitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BBT001, Placebo.
Who it may be relevant to
Registry conditions: Atopic Dermatitis. Basic parameters: 18 years — 72 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, New Zealand, Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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 Adult Patients With AD

Overview

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).

Detailed description

This study a is a randomized, double-blinded, placebo-controlled single (SAD) and multiple-ascending dose (MAD) study to evaluate safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics, and exploratory clinical activity of BBT001 in healthy volunteers (HVs) and in adult patients with atopic dermatitis. BBT001 is a drug candidate being developed for the treatment of atopic dermatitis.

Interventions

  • Drug BBT001
    BBT001 will be administered
  • Drug Placebo
    Placebo will be administered

Primary outcome measures

  • Number of participants with adverse events following single and multiple administration of BBT001 [Time frame: Parts A and D - Up to Day 141; Parts B, C, and E - Up to Day 169 post first dose administration]
  • Number of participants with change in serum blood parameters [Time frame: Parts A and D - Up to Day 141; Parts B, C, and E - Up to Day 169 post first dose administration]
  • Number of participants with change in vital sign measurements following treatment administration. [Time frame: Parts A and D - Up to Day 141; Parts B, C, and E - Up to Day 169 post first dose administration]
  • Number of participants with change in physical examination following treatment administration. [Time frame: Parts A and D - Up to Day 141; Parts B, C, and E - Up to Day 169 post first dose administration]
  • Number of participants with change in 12-lead ECG readings [Time frame: Parts A and D - Up to Day 141; Parts B, C, and E - Up to Day 169 post first dose administration]
Secondary outcome measures (7)
  • Pharmacokinetics parameters - maximum observed Concentration (Cmax) [Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration]
  • Pharmacokinetics parameters - Time for maximum observed Concentration (Tmax) [Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration]
  • Pharmacokinetics parameters - Area under the curve (AUC) [Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration]
  • Pharmacokinetics parameters - Volume of distribution (Vz) [Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration]
  • Pharmacokinetics parameters - Total clearance (CL) [Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration]
  • Pharmacokinetics parameters - Elimination Half-life (t1/2). [Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration]
  • The immunogenicity of BBT001 is measured as the number and percentage of subjects who develop Anti-Drug Antibodies (ADA). [Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration]

Eligibility criteria

Inclusion criteria

  • 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 Inclusion Criteria (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 Inclusion Criteria (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.

Exclusion criteria

  • 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.
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

New Zealand · 5 centers
  • Optimal Clinical Trials Central Auckland — Grafton
  • Aotearoa Clinical Trials — Otahuhu
  • Pacific Clinical Research Network (PCRN) - Auckland — Takapuna
  • Optimal Clinical Trials Ltd - Christchurch — Christchurch
  • Pacific Clinical Research Network (PCRN) Wellington — Upper Hutt
Poland · 4 centers
  • Wojewódzki Specjalistyczny Szpital im. Dr. Wł. Biegańskiego w Łodzi — Lodz
  • Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie — Rzeszów
  • Państwowy Instytut Medyczny MSWiA — Warsaw
  • Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska — Wroclaw
United States · 3 centers
  • First OC Dermatology — Irvine
  • OptiSkin Medical — New York
  • Equity Medical, LLC — The Bronx
Australia · 2 centers
  • Fremantle Dermatology — Fremantle
  • Linear Clinical Research — Perth

Identifiers

NCT: NCT06808477 · BBT001-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗