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
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for healthy adults (Part A) and adults with moderate to severe atopic dermatitis (Part B) to test the drug BBT001 against a placebo.
- Age
- 18 to 65 years
- Sex
- All sexes can join
- Disease stage
- Part B: chronic atopic dermatitis for at least 12 months, moderate to severe. vIGA-AD score of 3 or more, lesions covering 10% or more of body surface area, EASI score of 16 or more, peak itch score of 4 or more.
- Earlier treatment
- Part B: topical treatments did not work well enough or cannot be used. People who took biologics (IL-4/IL-13 or IL-31 pathway) or JAK inhibitors before can join. No immunoglobulin or blood products in the last 30 days.
Main reasons for not taking part
- Serious health problems such as diabetes, HIV, hepatitis B or C, immune problems, autoimmune disease or cancer
- History of drug or alcohol abuse in the past 2 years
- History of severe allergic reactions
- Part B: other skin diseases, or current use of sedating antihistamines or corticosteroids
- Part B: infections, or eye symptoms from atopic dermatitis
Read by machine on 12 November 2026.
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, ChinaContact: Jianzhong Zhang, Principle InvestigatorNot yet recruiting
- The Second Xiangya Hospital of Central South UniversityChangsha, ChinaContact: Yunsheng Liang, Principle InvestigatorNot yet recruiting
- Dermatology Hospital of Southern Medical UniversityGuangzhou, ChinaContact: Bin Yang, Principle InvestigatorNot yet recruiting
- The Second Hospital of Anhui Medical UnivesityHefei, ChinaContact: Wei Hu, Principle InvestigatorTaking people
- Shandong Provincial Hospital for Skin DiseasesJinan, ChinaContact: Furen Zhang, Principle InvestigatorNot yet recruiting
- Jiangxi Provincial Dermatology HospitalNanchang, ChinaContact: Guohong Hu, Principle InvestigatorNot yet recruiting
- Shanghai Dermatology HospitalShanghai, ChinaContact: Yangfeng DingNot yet recruiting
- the Second Affiliated Hospital of Wannan Medical CollegeWuhu, ChinaContact: Ruzhi Zhang, Principle InvestigatorNot yet recruiting
- Wuxi Second People's HospitalWuxi, ChinaContact: Xiaoli Zhang, Principle InvestigatorNot yet recruiting
- Jiangsu University Affiliated HospitalZhenjiang, ChinaContact: Yumei Li, Principle InvestigatorNot 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.