Testing BBT001 in healthy adults and adults with atopic dermatitis
Tests BBT001 against placebo in adults with moderate to severe atopic dermatitis.
Plain-language title generated from the registry record
Registry title: A Study of BBT001 in Healthy Volunteers (HVs) and in Adult Patients With Moderate to Severe Atopic Dermatitis (AD)
Key facts
- Where
- Beijing, Changsha, Guangzhou, Hefei, Jinan, Nanchang, Shanghai, Wuhu, Wuxi, and Zhenjiang, ChinaSee the 10 sites
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07239947, who can take part
Where in China
- Peking University People's HospitalBeijing, ChinaNot yet recruiting
- The Second Xiangya Hospital of Central South UniversityChangsha, ChinaNot yet recruiting
- Dermatology Hospital of Southern Medical UniversityGuangzhou, ChinaNot yet recruiting
- The Second Hospital of Anhui Medical UnivesityHefei, ChinaTaking people
- Shandong Provincial Hospital for Skin DiseasesJinan, ChinaNot yet recruiting
- Jiangxi Provincial Dermatology HospitalNanchang, ChinaNot yet recruiting
- Shanghai Dermatology HospitalShanghai, ChinaNot yet recruiting
- the Second Affiliated Hospital of Wannan Medical CollegeWuhu, ChinaNot yet recruiting
- Wuxi Second People's HospitalWuxi, ChinaNot yet recruiting
- Jiangsu University Affiliated HospitalZhenjiang, ChinaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Bambusa Therapeutics
- Trial code
- NCT07239947
- Record updated
- 22 July 2026
- Original description
This is a Phase 1, randomized, blinded, placebo controlled, single ascending dose (SAD) study of BBT001 in healthy volunteers (HVs) and adult patients with moderate to severe Atopic Dermatitis (AD).Read full original descriptionShow less
A Randomized, Blinded, Placebo-controlled, Single- and Multiple-ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics and Clinical Activity of BBT001 in HVs and AD Patient
This is a Phase 1, randomized, blinded, placebo controlled, single ascending dose (SAD) study of BBT001 in healthy volunteers (HVs) and adult patients with moderate to severe Atopic Dermatitis (AD).
Inclusion: Age of 18-65 years; Body mass index between 18-28 kg/m², capped at 120 kg; Negative pregnancy tests for women of childbearing potential; Willingness to refrain from alcohol consumption for 24 hours prior to each study visit; Non-smokers, healthy current smokers (≤5 cigarettes/day), or ex-smokers; Adequate contraception use (for men and women of childbearing potential); No clinically significant abnormalities or history of relevant diseases; Must have dermatologist-confirmed chronic atopic dermatitis (≥12 months). Inadequate response to topical treatments or where they are medically inadvisable; Moderate to severe atopic dermatitis; Validated investigator's global assessment for atopic dermatitis (vIGA-ADTM) score ≥3; Atopic lesions cover ≥10% of body surface area (BSA); Average peak pruritus numeric rating scale (PP-NRS) score ≥4 in the 7 days before randomization; Eczema Area and Severity Index (EASI) score ≥16 at screening and randomization visits; （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.
Exclusion: Positive drug/alcohol tests or abnormal vital signs at screening or Day -1; Atopic dermatitis with ocular symptoms or chronic ocular steroid use; Current use of sedating antihistamines or corticosteroids; 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; History of major metabolic, dermatological, liver, kidney, hematological, or other significant disorders; History of drug/alcohol abuse in the past 2 years; History of severe allergic reactions or hypersensitivity; Skin diseases other than atopic dermatitis, significant tattoos, or scarring; Chronic pruritus from conditions other than atopic dermatitis; Acute/treated infections or chronic skin infections; Clinically relevant abnormal lab results, including low blood counts, liver issues, or abnormal kidney function; Abnormal Electrocardiogram (ECG) findings; Donated >500mL blood within 2 months of screening; Receipt of immunoglobulin or blood products within 30 days.