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

NCT06808477 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: BBT001-001
• Study Type: interventional
• Target: 237
• Locations: 4 countries
• Sites: 14

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).

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (5)

• Number of participants with adverse events following single and multiple administration of BBT001

  Incidence, relatedness, and severity of adverse events graded per NCI CTCAE v5.0.

  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

  Laboratory assessments include hematology, blood chemistry and coagulation test

  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.

  Blood pressure and heart rate will be assessed.

  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.

  Physical examination will be assessed.

  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

  12-lead ECG will be assessed.

  Parts A and D - Up to Day 141; Parts B, C, and E - Up to Day 169 post first dose administration

Secondary Outcomes (7)

• Pharmacokinetics parameters - maximum observed Concentration (Cmax)

  At specified timepoints pre-dose and up to 169 days post first dose administration

• Pharmacokinetics parameters - Time for maximum observed Concentration (Tmax)

  At specified timepoints pre-dose and up to 169 days post first dose administration

• Pharmacokinetics parameters - Area under the curve (AUC)

  At specified timepoints pre-dose and up to 169 days post first dose administration

• Pharmacokinetics parameters - Volume of distribution (Vz)

  At specified timepoints pre-dose and up to 169 days post first dose administration

• Pharmacokinetics parameters - Total clearance (CL)

  At specified timepoints pre-dose and up to 169 days post first dose administration

Study Arms (11)

Part A Single Ascending Dose BBT001

EXPERIMENTAL

A single dose of BBT001 will be administered in healthy volunteers

Drug: BBT001

Part B Multiple Ascending Dose BBT001

EXPERIMENTAL

Multiple doses of BBT001 will be administered in healthy volunteers.

Drug: BBT001

Part C Multiple Ascending Dose BBT001

EXPERIMENTAL

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

Drug: BBT001

Part A Single Ascending Dose Placebo

PLACEBO COMPARATOR

A single dose of Placebo will be administered in healthy volunteers

Drug: Placebo

Part B Multiple Ascending Dose Placebo

PLACEBO COMPARATOR

Multiple doses of Placebo will be administered in healthy volunteers.

Drug: Placebo

Part C Multiple Ascending Dose Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Part D Single Ascending Dose BBT001

ACTIVE COMPARATOR

A single dose of BBT001 will be administered in healthy volunteers

Drug: BBT001

Part D Single Ascending Dose Placebo

PLACEBO COMPARATOR

A single dose of placebo will be administered in healthy volunteers

Drug: Placebo

Part E Multiple Ascending Dose BBT001 - Dose Level 1

ACTIVE COMPARATOR

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

Drug: BBT001

Part E Multiple Ascending Dose Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Part E Multiple Ascending Dose BBT001 - Dose Level 2

ACTIVE COMPARATOR

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

Drug: BBT001

Interventions

BBT001 DRUG

BBT001 will be administered

Part A Single Ascending Dose BBT001; Part B Multiple Ascending Dose BBT001; Part C Multiple Ascending Dose BBT001; Part D Single Ascending Dose BBT001; Part E Multiple Ascending Dose BBT001 - Dose Level 1; Part E Multiple Ascending Dose BBT001 - Dose Level 2

Placebo DRUG

Placebo will be administered

Part A Single Ascending Dose Placebo; Part B Multiple Ascending Dose Placebo; Part C Multiple Ascending Dose Placebo; Part D Single Ascending Dose Placebo; Part E Multiple Ascending Dose Placebo

Eligibility Criteria

• Age: 18 Years - 72 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.
• 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.

You may not qualify if:

• 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.
• \. History of atopic dermatitis
• 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.

Sponsors & Collaborators

• Bambusa Therapeutics: lead

Study Sites (14)

First OC Dermatology

Irvine, California, 92614, United States

NOT YET RECRUITING

OptiSkin Medical

New York, New York, 10128, United States

RECRUITING

Equity Medical, LLC

The Bronx, New York, 10455, United States

RECRUITING

Fremantle Dermatology

Fremantle, Western Australia, 6160, Australia

NOT YET RECRUITING

Linear Clinical Research

Perth, Western Australia, 6009, Australia

ACTIVE NOT RECRUITING

Optimal Clinical Trials Central Auckland

Grafton, Auckland, 1010, New Zealand

RECRUITING

Aotearoa Clinical Trials

Otahuhu, Auckland, 2025, New Zealand

WITHDRAWN

Pacific Clinical Research Network (PCRN) - Auckland

Takapuna, Auckland, 0622, New Zealand

RECRUITING

Optimal Clinical Trials Ltd - Christchurch

Christchurch, Christchurch, New Zealand

RECRUITING

Pacific Clinical Research Network (PCRN) Wellington

Upper Hutt, 5018, New Zealand

RECRUITING

Wojewódzki Specjalistyczny Szpital im. Dr. Wł. Biegańskiego w Łodzi

Lodz, 91-347, Poland

NOT YET RECRUITING

Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie

Rzeszów, 35-055, Poland

RECRUITING

Państwowy Instytut Medyczny MSWiA

Warsaw, 02-507, Poland

NOT YET RECRUITING

Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska

Wroclaw, 50-566, Poland

NOT YET RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Lisa Li

  Bambusa Therapeutics, Inc.

  STUDY DIRECTOR

Central Study Contacts

Lisa Li

CONTACT

+1 617-848-6188; Lisa.Li@bambusatx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2025
• First Posted: February 5, 2025
• Study Start: February 27, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: July 9, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

PL (4); AU (2); NZ (5); US (3)