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Study of BBT001 for Atopic Dermatitis

This study is testing a drug called BBT001 for atopic dermatitis (a skin condition causing itchy, inflamed patches). It's also being tested in healthy volunteers. Researchers want to see if BBT001 is safe and how your body handles it. They will also look for early signs of whether it helps with atopic dermatitis. The study is looking for adults aged 18 to 72, including those with moderate to severe atopic dermatitis. Success in this study means that BBT001 is shown to be safe, with few side effects, and that your body processes it as expected. The study aims to enroll 237 participants, but its current recruitment status is unclear.

Study design
This is a randomized, blinded, placebo-controlled study involving single and multiple doses of BBT001. It will include healthy volunteers and adult patients with atopic dermatitis, with a planned enrollment of 237 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety and blood changes for up to 141 or 169 days after their first dose, depending on the study part.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06808477

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

Recruiting
PHASE1Ages 18–72InterventionalTreatment
Bambusa Therapeutics
~237 participants
Updated 2026-08-13 on ClinicalTrials.gov
What's tested:BBT001Placebo

At a glance

Recruiting sites
11 of 14 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with adverse events following single and multiple administration of BBT001
Measured over Parts A and D - Up to Day 141; Parts B, C, and E - Up to Day 169 post first dose administration
+4 more outcomes measured

Conditions

Atopic Dermatitis

Explore related trials

Atopic Dermatitis

Where it's being run

14 sites across 6 states
Poland4
Auckland3
New York2
Western Australia2
New Zealand2
California1

Study leadership

  • Lisa Li · STUDY_DIRECTOR · Bambusa Therapeutics, Inc.

Who to contact

Lisa Li
[email protected]
+1 617-848-6188
Email the study team

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What this trial measures

  • Number of participants with adverse events following single and multiple administration of BBT001Parts 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 parametersParts 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.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.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 readingsParts 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.