Clinical Trials in China / NCT07239947
Recruiting
Phase 1
A Study of BBT001 in Healthy Volunteers (HVs) and in Adult Patients With Moderate to Severe Atopic Dermatitis (AD)
NCT07239947 · tracked via the Priya Life Science China tracker
Condition(s) studied
Atopic Dermatitis
Investigational drug(s) / intervention(s)
BBT001 →Placebo
BBT001: BBT001 will be administered
Placebo: Placebo will be administered
Study summary
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).
Eligibility
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.
Primary outcome measure(s)
- Number of participants with adverse events following single and multiple administration of BBT001 — Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration
Incidence, relatedness, and severity of adverse events graded per NCI CTCAE v5.0. - Number of participants with change in vital sign measurements following treatment administration. — Part A- Up to Day 141; Part B-Up to Day 169 post first dose administration
Blood pressure and heart rate will be assessed. - Number of participants with change in serum blood parameters. — Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration
Laboratory assessments include hematology, blood chemistry and coagulation test - Number of participants with change in physical examination following treatment administration. — Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration
Physical examination will be assessed. - Number of participants with change in 12-lead electrocardiogram (ECG) results measurements following treatment administration. — Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration
12-lead ECG will be tested at individual sites using sites' equipment and will be assessed.
Trial sites (10)
| Facility | City | Region | Status |
|---|---|---|---|
| The Second Hospital of Anhui Medical Univesity | Hefei | Anhui | Recruiting |
| The Second Affiliated Hospital of Wannan Medical College | Wuhu | Anhui | Not Yet Recruiting |
| Peking University People's Hospital | Beijing | Beijing Municipality | Not Yet Recruiting |
| Dermatology Hospital of Southern Medical University | Guangzhou | Guangdong | Not Yet Recruiting |
| The Second Xiangya Hospital of Central South University | Changsha | Hunan | Not Yet Recruiting |
| Wuxi Second People's Hospital | Wuxi | Jiangsu | Not Yet Recruiting |
| Jiangsu University Affiliated Hospital | Zhenjiang | Jiangsu | Not Yet Recruiting |
| Jiangxi Provincial Dermatology Hospital | Nanchang | Jiangxi | Not Yet Recruiting |
| Shandong Provincial Hospital for Skin Diseases | Jinan | Shandong | Not Yet Recruiting |
| Shanghai Dermatology Hospital | Shanghai | Shanghai Municipality | Not Yet Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07239947 on ClinicalTrials.gov ↗ ← All trials in China