NCT06808477 · Bambusa Therapeutics
A Study of BBT001 in Healthy Volunteers (HVs) and in Adult Patients With Atopic Dermatitis (AD)
What this study is about
This is a Phase 1, randomly assigned, 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).
View original scientific description
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).
Interventions
DRUG
BBT001
BBT001 will be administered
DRUG
Placebo
Placebo will be administered
Primary outcome measures
Number of participants with adverse events following single and multiple administration of BBT001
Time frame: Parts A and D - Up to Day 141; Parts B, C, and E - Up to Day 169 post first dose administration
Incidence, relatedness, and severity of adverse events graded per NCI CTCAE v5.0.
Number of participants with change in serum blood parameters
Time frame: Parts A and D - Up to Day 141; Parts B, C, and E - Up to Day 169 post first dose administration
Laboratory assessments include hematology, blood chemistry and coagulation test
Number of participants with change in vital sign measurements following treatment administration.
Time frame: Parts A and D - Up to Day 141; Parts B, C, and E - Up to Day 169 post first dose administration
Blood pressure and heart rate will be assessed.
Number of participants with change in physical examination following treatment administration.
Time frame: Parts A and D - Up to Day 141; Parts B, C, and E - Up to Day 169 post first dose administration
Physical examination will be assessed.
Number of participants with change in 12-lead ECG readings
Time frame: Parts A and D - Up to Day 141; Parts B, C, and E - Up to Day 169 post first dose administration
12-lead ECG will be assessed.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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). Key Inclusion Criteria (Parts A, B, and D)
- 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. Key Inclusion Criteria (Parts C and E only)
- 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. Key
Exclusion criteria
- 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. Key Exclusion Criteria (Parts A, B, and D only) 1\. History of atopic dermatitis Key Exclusion Criteria (Parts C and E only)
- 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.
Where
- Irvine, California
- New York, New York
- The Bronx, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 9, 2026 · Source of record for eligibility and locations