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

NCT ID: NCT06808477

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-27

Study Completion Date

2027-02-06

Brief Summary

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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

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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)

Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Part C Multiple Ascending Dose Placebo IV

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo will be administered

Part D Single Ascending Dose BBT001 SC

A single dose of BBT001 will be administered in healthy volunteers

Group Type ACTIVE_COMPARATOR

BBT001

Intervention Type DRUG

BBT001 will be administered

Part D Single Ascending Dose Placebo SC

A single dose of placebo will be administered in healthy volunteers

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo will be administered

Part E Multiple Ascending Dose BBT001 SC - Dose Level 1

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

Group Type ACTIVE_COMPARATOR

BBT001

Intervention Type DRUG

BBT001 will be administered

Part E Multiple Ascending Dose Placebo SC

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo will be administered

Part E Multiple Ascending Dose BBT001 SC - Dose Level 2

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

Group Type ACTIVE_COMPARATOR

BBT001

Intervention Type DRUG

BBT001 will be administered

Part A Single Ascending Dose BBT001 IV

A single dose of BBT001 will be administered in healthy volunteers

Group Type EXPERIMENTAL

BBT001

Intervention Type DRUG

BBT001 will be administered

Part B Multiple Ascending Dose BBT001 IV

Three doses of BBT001 will be administered in healthy volunteers.

Group Type EXPERIMENTAL

BBT001

Intervention Type DRUG

BBT001 will be administered

Part C Multiple Ascending Dose BBT001 IV

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

Group Type EXPERIMENTAL

BBT001

Intervention Type DRUG

BBT001 will be administered

Part A Single Ascending Dose Placebo IV

A single dose of Placebo will be administered in healthy volunteers

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo will be administered

Part B Multiple Ascending Dose Placebo IV

Three doses of Placebo will be administered in healthy volunteers.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo will be administered

Interventions

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BBT001

BBT001 will be administered

Intervention Type DRUG

Placebo

Placebo will be administered

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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.


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.

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.


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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bambusa Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lisa Li

Role: STUDY_DIRECTOR

Bambusa Therapeutics, Inc.

Locations

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Equity Medical, LLC

The Bronx, New York, United States

Site Status NOT_YET_RECRUITING

Linear Clinical Research

Perth, Western Australia, Australia

Site Status RECRUITING

Optimal Clinical Trials Central Auckland

Grafton, Auckland, New Zealand

Site Status RECRUITING

Aotearoa Clinical Trials

Otahuhu, Auckland, New Zealand

Site Status RECRUITING

Pacific Clinical Research Network (PCRN) - Auckland

Takapuna, Auckland, New Zealand

Site Status RECRUITING

Optimal Clinical Trials Ltd - Christchurch

Christchurch Central City, Christchurch, New Zealand

Site Status NOT_YET_RECRUITING

Pacific Clinical Research Network (PCRN) Wellington

Upper Hutt, , New Zealand

Site Status RECRUITING

Countries

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United States Australia New Zealand

Central Contacts

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Lisa Li

Role: CONTACT

Phone: +1 858 353 4948

Email: [email protected]

Facility Contacts

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Peter Schrader, Dr

Role: primary

Arna Letica

Role: primary

Cheng Huang

Role: primary

Paul Hamilton

Role: primary

Tim Humphrey

Role: primary

Other Identifiers

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BBT001-001

Identifier Type: -

Identifier Source: org_study_id