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New eczema drug enters first human tests

NCT ID NCT06808477

Symptom relief Sponsor: Bambusa Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 6 times

Summary

This early-stage study tests a new drug called BBT001 in healthy volunteers and adults with moderate-to-severe atopic dermatitis (eczema). The main goal is to check safety and how the drug moves through the body. About 198 participants will receive either BBT001 or a placebo, with doses increased gradually to find the right range.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 237 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 72 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

atopic eczema

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atopic dermatitis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    12 sites in 4 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aotearoa Clinical Trials

    WITHDRAWN

    Otahuhu, Auckland, 2025, New Zealand

  • Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska

    RECRUITING

    Wroclaw, 50-566, Poland

  • Equity Medical, LLC

    RECRUITING

    The Bronx, New York, 10455, United States

  • First OC Dermatology

    RECRUITING

    Irvine, California, 92614, United States

  • Fremantle Dermatology

    NOT_YET_RECRUITING

    Fremantle, Western Australia, 6160, Australia

  • Linear Clinical Research

    COMPLETED

    Perth, Western Australia, 6009, Australia

  • OptiSkin Medical

    RECRUITING

    New York, New York, 10128, United States

  • Optimal Clinical Trials Central Auckland

    RECRUITING

    Grafton, Auckland, 1010, New Zealand

  • Optimal Clinical Trials Ltd - Christchurch

    RECRUITING

    Christchurch, New Zealand

  • Pacific Clinical Research Network (PCRN) - Auckland

    RECRUITING

    Takapuna, Auckland, 0622, New Zealand

  • Pacific Clinical Research Network (PCRN) Wellington

    RECRUITING

    Upper Hutt, 5018, New Zealand

  • Państwowy Instytut Medyczny MSWiA

    RECRUITING

    Warsaw, 02-507, Poland

  • Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie

    RECRUITING

    Rzeszów, 35-055, Poland

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

    RECRUITING

    Lodz, 91-347, Poland

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