Actively Recruiting
A Study of BBT001 in Healthy Volunteers (HVs) and in Adult Patients With Moderate to Severe Atopic Dermatitis (AD)
Led by Bambusa Therapeutics · Updated on 2025-11-20
63
Participants Needed
10
Research Sites
84 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Study of BBT001 in Healthy Volunteers (HVs) and in Adult Patients With Moderate to Severe Atopic Dermatitis (AD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age of 18-65 years
- Body mass index between 18-28 kg/m8, 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 ( cigarettes/day), or ex-smokers
- Adequate contraception use for men and women of childbearing potential
- No clinically significant abnormalities or relevant disease history
- Dermatologist-confirmed chronic atopic dermatitis (12 months) for Part B
- Moderate to severe atopic dermatitis for Part B
- Validated investigator's global assessment score 3 for atopic dermatitis for Part B
- Atopic lesions covering 10% of body surface area for Part B
- Average peak pruritus numeric rating scale score 4 in the 7 days before randomization for Part B
- Eczema Area and Severity Index score 16 at screening and randomization for Part B
You will not qualify if you...
- Significant health issues such as diabetes, HIV, hepatitis C, hepatitis B, immunodeficiencies, autoimmune diseases, cancer, or history of infection risk
- History of major metabolic, dermatological, liver, kidney, hematological, or other significant disorders
- Clinically relevant abnormal lab results including low blood counts or abnormal liver or kidney function
- Positive drug or alcohol tests or abnormal vital signs at screening or Day -1
- Abnormal electrocardiogram findings
- History of drug or alcohol abuse in the past 2 years
- Donated more than 500 mL blood within 2 months of screening
- History of severe allergic reactions or hypersensitivity
- Skin diseases other than atopic dermatitis, significant tattoos, or scarring for Part B
- Receipt of immunoglobulin or blood products within 30 days for Part B
- Atopic dermatitis with ocular symptoms or chronic ocular steroid use for Part B
- Chronic pruritus from other causes for Part B
- Acute or treated infections or chronic skin infections for Part B
- Current use of sedating antihistamines or corticosteroids for Part B
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
The Second Hospital of Anhui Medical Univesity
Hefei, Anhui, China, 230601
Actively Recruiting
2
The Second Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China, 241001
Not Yet Recruiting
3
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100032
Not Yet Recruiting
4
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510440
Not Yet Recruiting
5
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China, 410011
Not Yet Recruiting
6
Wuxi Second People's Hospital
Wuxi, Jiangsu, China, 214002
Not Yet Recruiting
7
Jiangsu University Affiliated Hospital
Zhenjiang, Jiangsu, China, 212001
Not Yet Recruiting
8
Jiangxi Provincial Dermatology Hospital
Nanchang, Jiangxi, China, 330000
Not Yet Recruiting
9
Shandong Provincial Hospital for Skin Diseases
Jinan, Shandong, China, 250011
Not Yet Recruiting
10
Shanghai Dermatology Hospital
Shanghai, Shanghai Municipality, China, 200050
Not Yet Recruiting
Research Team
T
Tracy Ji
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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