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

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 Adult Patients With AD

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).

Study Overview

• Status: Recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Placebo; Drug: BBT001

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 237
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Lisa Li; Phone Number: +1 617-848-6188; Email: Lisa.Li@bambusatx.com

Study Locations

• Australia
  • Western Australia
    • Fremantle, Western Australia, Australia, 6160
      • Not yet recruiting
      • Fremantle Dermatology
    • Perth, Western Australia, Australia, 6009
      • Completed
      • Linear Clinical Research
• New Zealand
  • Christchurch, New Zealand
    • Recruiting
    • Optimal Clinical Trials Ltd - Christchurch
  • Upper Hutt, New Zealand, 5018
    • Recruiting
    • Pacific Clinical Research Network (PCRN) Wellington
    • Contact: Tim Humphrey
  • Auckland
    • Grafton, Auckland, New Zealand, 1010
      • Recruiting
      • Optimal Clinical Trials Central Auckland
      • Contact: Arna Letica
    • Otahuhu, Auckland, New Zealand, 2025
      • Withdrawn
      • Aotearoa Clinical Trials
    • Takapuna, Auckland, New Zealand, 0622
      • Recruiting
      • Pacific Clinical Research Network (PCRN) - Auckland
      • Contact: Paul Hamilton
• Poland
  • Lodz, Poland, 91-347
    • Recruiting
    • Wojewódzki Specjalistyczny Szpital im. Dr. Wł. Biegańskiego w Łodzi
  • Rzeszów, Poland, 35-055
    • Recruiting
    • Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie
  • Warsaw, Poland, 02-507
    • Recruiting
    • Państwowy Instytut Medyczny MSWiA
  • Wroclaw, Poland, 50-566
    • Recruiting
    • Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska
• United States
  • California
    • Irvine, California, United States, 92614
      • Recruiting
      • First OC Dermatology
  • New York
    • New York, New York, United States, 10128
      • Recruiting
      • OptiSkin Medical
    • The Bronx, New York, United States, 10455
      • Recruiting
      • Equity Medical, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

11

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A Single Ascending Dose BBT001; A single dose of BBT001 will be administered in healthy volunteers	Drug: BBT001; BBT001 will be administered
Placebo Comparator: Part A Single Ascending Dose Placebo; A single dose of Placebo will be administered in healthy volunteers	Drug: Placebo; Placebo will be administered
Experimental: Part B Multiple Ascending Dose BBT001; Multiple doses of BBT001 will be administered in healthy volunteers.	Drug: BBT001; BBT001 will be administered
Experimental: Part C Multiple Ascending Dose BBT001; Multiple doses of BBT001 will be administered in patients with atopic dermatitis.	Drug: BBT001; BBT001 will be administered
Placebo Comparator: Part B Multiple Ascending Dose Placebo; Multiple doses of Placebo will be administered in healthy volunteers.	Drug: Placebo; Placebo will be administered
Placebo Comparator: Part C Multiple Ascending Dose Placebo; Multiple doses of Placebo will be administered in patients with atopic dermatitis.	Drug: Placebo; Placebo will be administered
Active Comparator: Part D Single Ascending Dose BBT001; A single dose of BBT001 will be administered in healthy volunteers	Drug: BBT001; BBT001 will be administered
Placebo Comparator: Part D Single Ascending Dose Placebo; A single dose of placebo will be administered in healthy volunteers	Drug: Placebo; Placebo will be administered
Active Comparator: Part E Multiple Ascending Dose BBT001 - Dose Level 1; Multiple doses of BBT001 will be administered in patients with atopic dermatitis.	Drug: BBT001; BBT001 will be administered
Placebo Comparator: Part E Multiple Ascending Dose Placebo; Multiple doses of placebo will be administered in patients with atopic dermatitis.	Drug: Placebo; Placebo will be administered
Active Comparator: Part E Multiple Ascending Dose BBT001 - Dose Level 2; Multiple doses of BBT001 will be administered in patients with atopic dermatitis	Drug: BBT001; BBT001 will be administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The immunogenicity of BBT001 is measured as the number and percentage of subjects who develop Anti-Drug Antibodies (ADA).	Serum Anti-Drug Antibodies will be analyzed for all subjects	At specified timepoints pre-dose and up to 169 days post first dose administration
Pharmacokinetics parameters - maximum observed Concentration (Cmax)	Maximum observed concentration of the study drug in serum will be analyzed for all subjects	At specified timepoints pre-dose and up to 169 days post first dose administration
Pharmacokinetics parameters - Time for maximum observed Concentration (Tmax)	Serum PK Tmax will be analyzed for all subjects	At specified timepoints pre-dose and up to 169 days post first dose administration
Pharmacokinetics parameters - Area under the curve (AUC)	Area under the curve of the study drug in serum will be analyzed for all subjects	At specified timepoints pre-dose and up to 169 days post first dose administration
Pharmacokinetics parameters - Volume of distribution (Vz)	Volume of distribution of the study drug in serum will be analyzed for all subjects	At specified timepoints pre-dose and up to 169 days post first dose administration
Pharmacokinetics parameters - Total clearance (CL)	Total clearance of the study drug in serum will be analyzed for all subjects	At specified timepoints pre-dose and up to 169 days post first dose administration
Pharmacokinetics parameters - Elimination Half-life (t1/2).	Elimination half-life of the study drug in serum will be analyzed for all subjects	At specified timepoints pre-dose and up to 169 days post first dose administration

Collaborators and Investigators

• Sponsor: Bambusa Therapeutics
• Investigators: Study Director: Lisa Li, Bambusa Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027

Study Registration Dates

• First Submitted: January 30, 2025
• First Submitted That Met QC Criteria: January 30, 2025
• First Posted (Actual): February 5, 2025

Study Record Updates

• Last Update Posted (Actual): August 13, 2026
• Last Update Submitted That Met QC Criteria: August 12, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Dermatitis, Atopic
• Other Study ID Numbers: BBT001-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No