BBT001 in healthy adults and adults with moderate to severe atopic dermatitis

A Randomized, Blinded, Placebo-controlled, Single- and Multiple-ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics and Clinical Activity of BBT001 in HVs and AD Patient

This trial tests whether single and repeated doses of BBT001 are safe and well tolerated in healthy adults and in adults with moderate to severe atopic dermatitis.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 63 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Bambusa Therapeutics (Industry-sponsored)
• Locations: 10 sites (Hefei, Anhui and 9 other locations)
• Trial ID: NCT07239947 on ClinicalTrials.gov

What this trial studies

This Phase 1, randomized, blinded, placebo-controlled trial has two parts: a single-ascending-dose (SAD) section in healthy volunteers and a multiple-ascending-dose (MAD) section with seven repeated doses in adults with moderate to severe atopic dermatitis. Part A enrolls sequential dose cohorts of healthy volunteers to define safety, tolerability, and pharmacokinetics after a single dose. Part B enrolls adults with dermatologist-confirmed chronic AD and escalates repeated doses to collect safety, tolerability, and preliminary symptom data. Participants are randomized to receive BBT001 or placebo and are monitored with clinical exams, laboratory tests, and standardized skin and itch assessments.

Who should consider this trial

Good fit: Ideal participants are adults aged 18–65 who either serve as healthy volunteers for the single-dose cohorts or have dermatologist-confirmed chronic moderate to severe atopic dermatitis (vIGA-AD ≥3, ≥10% BSA affected, and average peak pruritus ≥4) and meet BMI and contraception requirements.

Not a fit: People with mild atopic dermatitis, uncontrolled significant medical conditions, pregnancy or breastfeeding, BMI or age outside the study limits, or who cannot attend visits at the listed sites are unlikely to receive benefit from this Phase 1 trial.

Why it matters

Potential benefit: If successful, BBT001 could provide a new treatment option that reduces inflammation and itching for people with moderate to severe atopic dermatitis.

How similar studies have performed: Other targeted biologic therapies for atopic dermatitis have shown meaningful benefits in later-phase trials, but BBT001 itself is novel and has not yet been tested in larger patient studies.

Eligibility criteria

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.

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.

Where this trial is running

Hefei, Anhui and 9 other locations

• The Second Hospital of Anhui Medical Univesity — Hefei, Anhui, China (Recruiting)
• The Second Affiliated Hospital of Wannan Medical College — Wuhu, Anhui, China (Not_yet_recruiting)
• Peking University People's Hospital — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• Dermatology Hospital of Southern Medical University — Guangzhou, Guangdong, China (Not_yet_recruiting)
• The Second Xiangya Hospital of Central South University — Changsha, Hunan, China (Not_yet_recruiting)
• Wuxi Second People's Hospital — Wuxi, Jiangsu, China (Not_yet_recruiting)
• Jiangsu University Affiliated Hospital — Zhenjiang, Jiangsu, China (Not_yet_recruiting)
• Jiangxi Provincial Dermatology Hospital — Nanchang, Jiangxi, China (Not_yet_recruiting)
• Shandong Provincial Hospital for Skin Diseases — Jinan, Shandong, China (Not_yet_recruiting)
• Shanghai Dermatology Hospital — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Tracy Ji

Conditions Atopic Dermatitis