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RecruitingNCT07239947Updated Jul 22, 2026

A Study of BBT001 in Healthy Volunteers (HVs) and in Adult Patients With Moderate to Severe Atopic Dermatitis (AD)

A Phase 1 interventional study of BBT001 and Placebo in Atopic Dermatitis, sponsored by Bambusa Therapeutics. Recruiting at 10 sites in China. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-22.

Sponsored by Bambusa Therapeutics · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
99
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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).

Read the detailed description

The study consists of two parts:

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)

02

Conditions studied

  • Atopic Dermatitis

Browse trials for

03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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.
  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.
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
99 participants (estimated)

Study arms

  • Experimental
    Part A -BBT001(Single Ascending Dose)

    A single dose of BBT001 will be administered in healthy volunteers

    Drug: BBT001

  • Experimental
    Part A- Placebo(Single Ascending Dose)

    A single dose of Placebo will be administered in healthy volunteers

    Drug: Placebo

  • Experimental
    Part B- BBT001(Multiple Ascending Dose)

    Seven repeat doses of BBT001 will be administered in patients with moderate to severe atopic dermatitis

    Drug: BBT001

  • Experimental
    Part B -Placebo (Multiple Ascending Dose))

    Seven repeat doses of Placebo will be administered in patients with moderate to severe atopic dermatitis

    Drug: Placebo

Interventions

  • DrugBBT001

    BBT001 will be administered

  • DrugPlacebo

    Placebo will be administered

05

What researchers measure

Primary outcomes

  1. Number of participants with adverse events following single and multiple administration of BBT001

    Incidence, relatedness, and severity of adverse events graded per NCI CTCAE v5.0.

    Time frame: Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration

  2. Number of participants with change in vital sign measurements following treatment administration.

    Blood pressure and heart rate will be assessed.

    Time frame: Part A- Up to Day 141; Part B-Up to Day 169 post first dose administration

  3. Number of participants with change in serum blood parameters.

    Laboratory assessments include hematology, blood chemistry and coagulation test

    Time frame: Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration

  4. Number of participants with change in physical examination following treatment administration.

    Physical examination will be assessed.

    Time frame: Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration

  5. Number of participants with change in 12-lead electrocardiogram (ECG) results measurements following treatment administration.

    12-lead ECG will be tested at individual sites using sites' equipment and will be assessed.

    Time frame: Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration

Secondary outcomes

  1. Pharmacokinetics parameters- maximum observed Concentration (Cmax)

    Maximum observed concentration of the study drug in serum will be analyzed for all subjects.

    Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration.

  2. Pharmacokinetics parameters- Time for maximum observed Concentration (Tmax)

    Serum PK Tmax will be analyzed for all subjects

    Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration

  3. Pharmacokinetics parameters- Area under the curve (AUC)

    Area under the curve of the study drug in serum will be analyzed for all subjects

    Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration

  4. Pharmacokinetics parameters- Volume of distribution (Vz)

    Volume of distribution of the study drug in serum will be analyzed for all subjects

    Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration

  5. Pharmacokinetics parameters- Total clearance (CL)

    Total clearance of the study drug in serum will be analyzed for all subjects

    Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration

  6. Pharmacokinetics parameters- - Elimination Half-life (t1/2).

    Elimination half-life of the study drug in serum will be analyzed for all subjects

    Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration

  7. The immunogenicity of BBT001 is measured as the number and percentage of subjects who develop Anti-Drug Antibodies (ADA).

    Serum Anti-Drug Antibodies will be analyzed for all subjects

    Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration

06

Study locations

1 of 10 sites recruiting
  • The Second Hospital of Anhui Medical Univesity
    Hefei, Anhui 230601, China
    • Wei Hu, Principle Investigator · Contact · hwgcp@ayefy.com · 0551-63869420
    • Chunjun Yang · Principal investigator
    Recruiting
  • The Second Affiliated Hospital of Wannan Medical College
    Wuhu, Anhui 241001, China
    Not yet recruiting
  • Peking University People's Hospital
    Beijing, Beijing Municipality 100032, China
    • Jianzhong Zhang, Principle Investigator · Contact · rmzjz@126.com · 010-88324516
    Not yet recruiting
  • Dermatology Hospital of Southern Medical University
    Guangzhou, Guangdong 510440, China
    Not yet recruiting
  • The Second Xiangya Hospital of Central South University
    Changsha, Hunan 410011, China
    Not yet recruiting
  • Wuxi Second People's Hospital
    Wuxi, Jiangsu 214002, China
    • Xiaoli Zhang, Principle Investigator · Contact · zxl415@163.com · 0510-68562222
    Not yet recruiting
  • Jiangsu University Affiliated Hospital
    Zhenjiang, Jiangsu 212001, China
    Not yet recruiting
  • Jiangxi Provincial Dermatology Hospital
    Nanchang, Jiangxi 330000, China
    • Guohong Hu, Principle Investigator · Contact · 20079850@qq.com · 0791-85214720
    Not yet recruiting
  • Shandong Provincial Hospital for Skin Diseases
    Jinan, Shandong 250011, China
    Not yet recruiting
  • Shanghai Dermatology Hospital
    Shanghai, Shanghai Municipality 200050, China
    Not yet recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07239947
Lead sponsor
Bambusa Therapeutics
Responsible party
Sponsor
First posted
Nov 20, 2025
Start date
Aug 9, 2025
Primary completion
Dec 31, 2027 (estimated)
Completion
Jun 30, 2028 (estimated)
Last update
Jul 22, 2026

Study contacts

Tracy Ji
Contact
tracy.ji@bambusatx.com
+86 18001322760
Tracy Ji
study director · Bambusa (Beijing) Therapeutics Co., Ltd.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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