Clinical trial NCT06808477: A Study of BBT001 in Healthy Volunteers (HVs) and in Adult Patients With Atopic Dermatitis (AD)
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Atopic Dermatitis
Lead sponsor: Bambusa Therapeutics
Sponsor class: INDUSTRY
First posted: 2025-02-05
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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).

Detailed description: The study consists of three parts:

* Part A (single dose in HVs in sequential ascending dose cohorts, SAD in HVs part)
* Part B (three repeated doses in HVs in sequential ascending dose cohorts, MAD in HVs part)
* Part C (three repeated doses in patients with moderate to severe AD, MAD in patients part)

Eligibility criteria: Key Inclusion Criteria (Part A, B, C)

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 (Part C 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)

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 (Part C 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.

Primary outcomes:
measure: Number of participants with adverse events following single and multiple administration of BBT001
timeFrame: Part A- Up to Day 141; Part B and C- Up to Day 169 post first dose administration
measure: Number of participants with change in serum blood parameters
timeFrame: Part A- Up to Day 141; Part B and C- Up to Day 169 post first dose administration
measure: Number of participants with change in vital sign measurements following treatment administration.
timeFrame: Part A- Up to Day 141; Part B and C- Up to Day 169 post first dose administration
measure: Number of participants with change in physical examination following treatment administration.
timeFrame: Part A- Up to Day 141; Part B and C- Up to Day 169 post first dose administration
Secondary outcomes:
measure: Pharmacokinetics parameters- maximum observed Concentration (Cmax)
timeFrame: At specified timepoints pre-dose and up to 169 days post first dose administration
measure: Pharmacokinetics parameters- Time for maximum observed Concentration (Tmax)
timeFrame: At specified timepoints pre-dose and up to 169 days post first dose administration
measure: Pharmacokinetics parameters- Area under the curve (AUC)
timeFrame: At specified timepoints pre-dose and up to 169 days post first dose administration
measure: Pharmacokinetics parameters- Volume of distribution (Vz)
timeFrame: At specified timepoints pre-dose and up to 169 days post first dose administration
measure: Pharmacokinetics parameters- Total clearance (CL)
timeFrame: At specified timepoints pre-dose and up to 169 days post first dose administration
measure: Pharmacokinetics parameters- - Elimination Half-life (t1/2).
timeFrame: At specified timepoints pre-dose and up to 169 days post first dose administration
measure: The immunogenicity of BBT001 is measured as the number and percentage of subjects who develop Anti-Drug Antibodies (ADA).
timeFrame: At specified timepoints pre-dose and up to 169 days post first dose administration
Other outcomes:
Locations:
city: Perth
country: Australia
facility: Linear Clinical Research
state: Western Australia
Study officials:
affiliation: Bambusa Therapeutics, Inc.
name: Lisa Li
role: STUDY_DIRECTOR
References: