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

Bambusa Therapeutics

Status and phase: Enrolling; Phase 1

Conditions: Atopic Dermatitis

Treatments: Drug: BBT001; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06808477

BBT001-001

Details and patient eligibility

About

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).

Full 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.

Enrollment: 237 estimated patients

Sex: All

Ages: 18 to 72 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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237 participants in 11 patient groups, including a placebo group

Part A Single Ascending Dose BBT001

Experimental group

Description:

A single dose of BBT001 will be administered in healthy volunteers

Treatment:

Drug: BBT001

Part B Multiple Ascending Dose BBT001

Experimental group

Description:

Multiple doses of BBT001 will be administered in healthy volunteers.

Treatment:

Drug: BBT001

Part C Multiple Ascending Dose BBT001

Experimental group

Description:

Multiple doses of BBT001 will be administered in patients with atopic dermatitis.

Treatment:

Drug: BBT001

Part A Single Ascending Dose Placebo

Placebo Comparator group

Description:

A single dose of Placebo will be administered in healthy volunteers

Treatment:

Drug: Placebo

Part B Multiple Ascending Dose Placebo

Placebo Comparator group

Description:

Multiple doses of Placebo will be administered in healthy volunteers.

Treatment:

Drug: Placebo

Part C Multiple Ascending Dose Placebo

Placebo Comparator group

Description:

Multiple doses of Placebo will be administered in patients with atopic dermatitis.

Treatment:

Drug: Placebo

Part D Single Ascending Dose BBT001

Active Comparator group

Description:

A single dose of BBT001 will be administered in healthy volunteers

Treatment:

Drug: BBT001

Part D Single Ascending Dose Placebo

Placebo Comparator group

Description:

A single dose of placebo will be administered in healthy volunteers

Treatment:

Drug: Placebo

Part E Multiple Ascending Dose BBT001 - Dose Level 1

Active Comparator group

Description:

Multiple doses of BBT001 will be administered in patients with atopic dermatitis.

Treatment:

Drug: BBT001

Part E Multiple Ascending Dose Placebo

Placebo Comparator group

Description:

Multiple doses of placebo will be administered in patients with atopic dermatitis.

Treatment:

Drug: Placebo

Part E Multiple Ascending Dose BBT001 - Dose Level 2

Active Comparator group

Description:

Multiple doses of BBT001 will be administered in patients with atopic dermatitis

Treatment:

Drug: BBT001