A Study of BBT001 in Healthy Volunteers (HVs) and in Adult Patients With Moderate to Severe Atopic Dermatitis (AD)
NCT ID: NCT07239947
Last Updated: 2025-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
63 participants
INTERVENTIONAL
2025-08-09
2027-03-26
Brief Summary
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Detailed Description
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Part A (single dose in HVs in sequential ascending dose cohorts, SAD in HVs part) Part B (seven repeated doses in patients with moderate to severe AD, multiple ascending Dose in patients part)
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
TRIPLE
Study Groups
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Part A -BBT001(Single Ascending Dose)
A single dose of BBT001 will be administered in healthy volunteers
BBT001
BBT001 will be administered
Part A- Placebo(Single Ascending Dose)
A single dose of Placebo will be administered in healthy volunteers
Placebo
Placebo will be administered
Part B- BBT001(Multiple Ascending Dose)
Seven repeat doses of BBT001 will be administered in patients with moderate to severe atopic dermatitis
BBT001
BBT001 will be administered
Part B -Placebo (Multiple Ascending Dose))
Seven repeat doses of Placebo will be administered in patients with moderate to severe atopic dermatitis
Placebo
Placebo will be administered
Interventions
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BBT001
BBT001 will be administered
Placebo
Placebo will be administered
Eligibility Criteria
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Inclusion Criteria
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.
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.
Exclusion Criteria
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.
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.
18 Years
65 Years
ALL
Yes
Sponsors
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Bambusa Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Tracy Ji
Role: STUDY_DIRECTOR
Bambusa (Beijing) Therapeutics Co., Ltd.
Locations
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The Second Hospital of Anhui Medical Univesity
Hefei, Anhui, China
The Second Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Wuxi Second People's Hospital
Wuxi, Jiangsu, China
Jiangsu University Affiliated Hospital
Zhenjiang, Jiangsu, China
Jiangxi Provincial Dermatology Hospital
Nanchang, Jiangxi, China
Shandong Provincial Hospital for Skin Diseases
Jinan, Shandong, China
Shanghai Dermatology Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BBT001-002
Identifier Type: -
Identifier Source: org_study_id
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