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
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
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
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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.