BBT001 in healthy adults and adults with moderate to severe atopic dermatitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1, randomized, blinded, placebo-controlled trial has two parts: a single-ascending-dose (SAD) section in healthy volunteers and a multiple-ascending-dose (MAD) section with seven repeated doses in adults with moderate to severe atopic dermatitis. Part A enrolls sequential dose cohorts of healthy volunteers to define safety, tolerability, and pharmacokinetics after a single dose. Part B enrolls adults with dermatologist-confirmed chronic AD and escalates repeated doses to collect safety, tolerability, and preliminary symptom data. Participants are randomized to receive BBT001 or placebo and are monitored with clinical exams, laboratory tests, and standardized skin and itch assessments.

Why it matters

Who can join: the full rules

Key Inclusion Criteria ( Part A and B):

1. Age of 18-65 years.
2. Body mass index between 18-28 kg/m², capped at 120 kg.
3. Negative pregnancy tests for women of childbearing potential.
4. Willingness to refrain from alcohol consumption for 24 hours prior to each study visit.
5. Non-smokers, healthy current smokers (≤5 cigarettes/day), or ex-smokers.
6. Adequate contraception use (for men and women of childbearing potential).
7. No clinically significant abnormalities or history of relevant diseases.

Key Inclusion Criteria (Part B only):

1. Must have dermatologist-confirmed chronic atopic dermatitis (≥12 months). Inadequate response to topical treatments or where they are medically inadvisable.
2. Moderate to severe atopic dermatitis
3. Validated investigator's global assessment for atopic dermatitis (vIGA-ADTM) score ≥3
4. Atopic lesions cover ≥10% of body surface area (BSA)
5. Average peak pruritus numeric rating scale (PP-NRS) score ≥4 in the 7 days before randomization.
6. Eczema Area and Severity Index (EASI) score ≥16 at screening and randomization visits.
7. （for biologic/JAKi experienced subjects) Patients with prior systemic exposure to the following agents are eligible for enrollment: biologics targeting IL-4/IL-13 or IL-31 pathway or JAK inhibitors.

Key Exclusion Criteria for (Part A\&B)

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 for (Part B 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.

Where it's running

• The Second Hospital of Anhui Medical Univesity
  Hefei, Anhui, China Recruiting
• The Second Affiliated Hospital of Wannan Medical College
  Wuhu, Anhui, China Not yet recruiting
• Peking University People's Hospital
  Beijing, Beijing Municipality, China Not yet recruiting
• Dermatology Hospital of Southern Medical University
  Guangzhou, Guangdong, China Not yet recruiting
• The Second Xiangya Hospital of Central South University
  Changsha, Hunan, China Not yet recruiting
• Wuxi Second People's Hospital
  Wuxi, Jiangsu, China Not yet recruiting

Study contacts

• Study coordinator: Tracy Ji
• Email: tracy.ji@bambusatx.com
• Phone: +86 18001322760

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.