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

Bambusa Therapeutics

Status and phase: Enrolling; Phase 1

Conditions: Atopic Dermatitis

Treatments: Drug: Placebo; Drug: BBT001

Study type: Interventional

Funder types: Industry

Identifiers

NCT07239947

BBT001-002

Details and patient eligibility

About

This is a Phase 1, randomized, blinded, placebo controlled, single ascending dose (SAD) study of BBT001 in healthy volunteers (HVs) and adult patients with moderate to severe Atopic Dermatitis (AD).

Full description

The study consists of two parts:

Part A (single dose in HVs in sequential ascending dose cohorts, SAD in HVs part) Part B (seven repeated doses in patients with moderate to severe AD, multiple ascending Dose in patients part)

Enrollment: 63 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria ( Part A and B):

1. Age of 18-65 years.
2. Body mass index between 18-28 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 B 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.
6. Eczema Area and Severity Index (EASI) score ≥16 at screening and randomization visits.

Key Exclusion Criteria for (Part A&B)

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 B 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: Sequential Assignment

Masking: Triple Blind

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63 participants in 4 patient groups

Part A -BBT001(Single Ascending Dose)

Experimental group

Description:

A single dose of BBT001 will be administered in healthy volunteers

Treatment:

Drug: BBT001

Part A- Placebo(Single Ascending Dose)

Experimental group

Description:

A single dose of Placebo will be administered in healthy volunteers

Treatment:

Drug: Placebo

Part B- BBT001(Multiple Ascending Dose)

Experimental group

Description:

Seven repeat doses of BBT001 will be administered in patients with moderate to severe atopic dermatitis

Treatment:

Drug: BBT001

Part B -Placebo (Multiple Ascending Dose))

Experimental group

Description:

Seven repeat doses of Placebo will be administered in patients with moderate to severe atopic dermatitis

Treatment:

Drug: Placebo