Phase 1 Eczema Trial, Recruiting NCT06808477 Sponsor: Bambusa Therapeutics Condition: Eczema
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Phase 1 Eczema Trial, Recruiting

NCT06808477
Recruiting Phase 1 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

For all parts of the trial:

  • Women of childbearing potential must have a negative pregnancy test
  • People who are willing to avoid alcohol for 24 hours before each study visit
  • People who are non-smokers, light current smokers (5 or fewer cigarettes per day), or former smokers
  • People who use adequate contraception (applies to both men and women who could potentially have children)

For Parts A, B, and D only (healthy volunteer sections):

  • People aged 18 to 65 years
  • People with a body mass index (a measure of body weight relative to height) between 18 and 32, and who weigh no more than 120 kg
  • People with no significant health conditions or relevant medical history

For Parts C and E only (atopic dermatitis sections):

  • People aged 18 to 72 years
  • People with a body mass index of 16 or above, and who weigh no more than 125 kg
  • People who have had atopic dermatitis (a type of eczema) for at least 12 months, confirmed by a dermatologist, and whose condition has not responded well enough to creams or ointments, or for whom those treatments are not medically suitable
  • People with moderate to severe atopic dermatitis
  • People whose dermatitis scores at least 3 on a standard medical assessment scale used by doctors (confirm with trial site)
  • People whose eczema-affected skin covers at least 10% of their body surface
  • People who have reported an average itch score of at least 4 out of 10 over the 7 days before joining the trial

Who may not be able to join:

For all parts of the trial:

  • People with significant health conditions such as diabetes, HIV, hepatitis B or C, immune system disorders, autoimmune diseases, cancer, or a history of frequent or serious infections
  • People with a history of major disorders affecting metabolism, skin, liver, kidneys, or blood
  • People with notably abnormal blood test results, including low blood counts, liver problems, or poor kidney function
  • People who test positive for drugs or alcohol, or who have abnormal vital signs (such as blood pressure or heart rate) at the screening visit or the day before the study starts
  • People with abnormal heart tracing (ECG) results
  • People with a history of drug or alcohol misuse in the past 2 years
  • People who have donated more than 500 mL of blood within 2 months before screening
  • People with a history of severe allergic reactions or serious sensitivities to medications

For Parts A, B, and D only:

  • People who have a history of atopic dermatitis (eczema)

For Parts C and E only:

  • People with skin diseases other than atopic dermatitis, or who have significant tattoos or scarring that may affect assessment
  • People who have received immunoglobulin or blood products within the past 30 days
  • People whose atopic dermatitis affects their eyes, or who have used steroid eye drops long-term
  • People who experience ongoing itch due to a condition other than atopic dermatitis
  • People with active, recently treated, or long-term skin infections
  • People currently using sedating antihistamines (certain allergy medications that cause drowsiness) or corticosteroid medications

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Lisa Li, Bambusa Therapeutics, Inc.

Phone: +1 617-848-6188

Australian sites

Fremantle Dermatology, Fremantle, Western Australia
Linear Clinical Research, Perth, Western Australia

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Sponsor
Bambusa Therapeutics
Registry
ClinicalTrials.gov
Start date
27 February 2025
Est. completion
28 February 2027

Where this trial is recruiting

🇦🇺 Australia 🇳🇿 New Zealand 🇵🇱 Poland 🇺🇸 United States

2 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Number of participants with adverse events following single and multiple administration of BBT001; Number of participants with change in serum blood parameters; Number of participants with change in vital sign measurements following treatment administration.; Number of participants with change in physical examination following treatment administration.; Number of participants with change in 12-lead ECG readings

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov