Actively Recruiting
A Study of BBT001 in Healthy Volunteers (HVs) and in Adult Patients With Atopic Dermatitis (AD)
Led by Bambusa Therapeutics · Updated on 2025-11-17
198
Participants Needed
7
Research Sites
101 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) and multiple ascending dose (MAD) 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 Atopic Dermatitis (AD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 65 years
- Body mass index between 18 and 32 kg/m², maximum 120 kg
- Negative pregnancy tests for women who can become pregnant
- Willing to avoid alcohol for 24 hours before each study visit
- Non-smokers, healthy smokers (5 or fewer cigarettes/day), or ex-smokers
- Use adequate contraception if applicable
- No significant health problems or history of relevant diseases
- For patients with atopic dermatitis (Parts C and E only): dermatologist-confirmed chronic atopic dermatitis for 12 months or more
- Moderate to severe atopic dermatitis
- Investigator's global assessment score of 3 or higher for atopic dermatitis
- Atopic lesions covering 10% or more of body surface area
- Average peak itch score of 4 or higher in the 7 days before randomization
You will not qualify if you...
- Significant health issues including diabetes, HIV, hepatitis C, hepatitis B, immunodeficiencies, autoimmune diseases, cancer, or history of infections
- History of major metabolic, skin, liver, kidney, blood, or other serious disorders
- Abnormal lab results such as low blood counts or poor kidney or liver function
- Positive drug or alcohol tests or abnormal vital signs at screening or Day -1
- Abnormal ECG findings
- History of drug or alcohol abuse in past 2 years
- Blood donation of more than 500 mL within 2 months before screening
- History of severe allergic reactions or hypersensitivity
- For patients with atopic dermatitis (Parts C and E only): other skin diseases, significant tattoos or scarring
- Recent use (within 30 days) of immunoglobulin or blood products
- Atopic dermatitis with eye symptoms or chronic steroid eye use
- Chronic itch from causes other than atopic dermatitis
- Acute or chronic skin infections
- Current use of sedating antihistamines or corticosteroids
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Equity Medical, LLC
The Bronx, New York, United States, 10455
Not Yet Recruiting
2
Linear Clinical Research
Perth, Western Australia, Australia, 6009
Actively Recruiting
3
Optimal Clinical Trials Central Auckland
Grafton, Auckland, New Zealand, 1010
Actively Recruiting
4
Aotearoa Clinical Trials
Otahuhu, Auckland, New Zealand, 2025
Actively Recruiting
5
Pacific Clinical Research Network (PCRN) - Auckland
Takapuna, Auckland, New Zealand, 0622
Actively Recruiting
6
Optimal Clinical Trials Ltd - Christchurch
Christchurch Central City, Christchurch, New Zealand
Not Yet Recruiting
7
Pacific Clinical Research Network (PCRN) Wellington
Upper Hutt, New Zealand, 5018
Actively Recruiting
Research Team
L
Lisa Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
11
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