Phase 1 Eczema Trial, Recruiting NCT07239947 Sponsor: Bambusa Therapeutics Condition: Eczema
Back to Eczema

Phase 1 Eczema Trial, Recruiting

NCT07239947
Recruiting Phase 1

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 participants (Part A and Part B):

  • People aged between 18 and 65 years old
  • People with a body mass index (a measure of body weight relative to height) between 18 and 28, and who weigh no more than 120 kg
  • Women who could become pregnant must have a negative pregnancy test
  • People who are willing to avoid alcohol for 24 hours before each study visit
  • People who do not smoke, smoke no more than 5 cigarettes per day, or who have previously smoked but no longer do
  • People who are using adequate contraception (applies to both men and women who could become pregnant)
  • People with no significant medical conditions or relevant medical history

For Part B participants only (in addition to the above):

  • People who have had atopic dermatitis (a type of chronic eczema) for at least 12 months, confirmed by a dermatologist
  • People whose atopic dermatitis has not responded well enough to skin-based treatments, or for whom those treatments are not medically appropriate
  • People with moderate to severe atopic dermatitis
  • People whose dermatologist rates their condition at a score of 3 or higher on a recognised severity scale (vIGA-AD™) (confirm with trial site)
  • People whose eczema-affected skin covers at least 10% of their body surface area
  • People who have reported an average itch score of 4 or higher (on a scale of 0–10) over the 7 days before being assigned to a treatment group
  • People who score 16 or higher on a recognised eczema severity measurement tool (EASI) at both their initial check and their treatment assignment visit

Who may not be able to join:

For all participants (Part A and Part B):

  • People with significant health conditions such as diabetes, HIV, hepatitis B or C, immune system disorders, autoimmune diseases, cancer, or a history of conditions that increase the risk of infections
  • People with a significant history of metabolic, skin, liver, kidney, blood, or other major health disorders
  • People with notably abnormal blood test results, including low blood counts, liver abnormalities, or impaired 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 begins
  • 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 in the 2 months before screening
  • People with a history of severe allergic reactions or serious hypersensitivity

For Part B participants only (in addition to the above):

  • People who have skin conditions 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 30 days before the study
  • People whose atopic dermatitis affects their eyes, or who regularly use steroid eye drops or ointments
  • People who experience chronic itch caused by a condition other than atopic dermatitis
  • People with active, recently treated, or ongoing chronic skin infections
  • People currently using sedating antihistamines 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 22 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: Tracy Ji, Bambusa (Beijing) Therapeutics Co., Ltd.

Phone: +86 18001322760

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
9 August 2025
Est. completion
31 December 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

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

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: 22 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