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

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 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).

Study Overview

• Status: Recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Placebo; Drug: BBT001

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)

• Study Type: Interventional
• Enrollment (Estimated): 63
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Tracy Ji; Phone Number: +86 18001322760; Email: tracy.ji@bambusatx.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230601
      • Recruiting
      • The Second Hospital of Anhui Medical Univesity
      • Principal Investigator: Chunjun Yang
      • Contact: Wei Hu, Principle Investigator; Phone Number: 0551-63869420; Email: hwgcp@ayefy.com
    • Wuhu, Anhui, China, 241001
      • Not yet recruiting
      • The Second Affiliated Hospital of Wannan Medical College
      • Contact: Ruzhi Zhang, Principle Investigator; Phone Number: 0553-2871846; Email: zhangruzhi628@163.com
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100032
      • Not yet recruiting
      • Peking University People's Hospital
      • Contact: Jianzhong Zhang, Principle Investigator; Phone Number: 010-88324516; Email: rmzjz@126.com
  • Guangdong
    • Guangzhou, Guangdong, China, 510440
      • Not yet recruiting
      • Dermatology Hospital of Southern Medical University
      • Contact: Bin Yang, Principle Investigator; Phone Number: 020-8306 8888; Email: yangbin101@hotmail.com
  • Hunan
    • Changsha, Hunan, China, 410011
      • Not yet recruiting
      • The Second Xiangya Hospital Of Central South University
      • Contact: Yunsheng Liang, Principle Investigator; Phone Number: 0553-2871846; Email: yunshenglianggcp@163.com
  • Jiangsu
    • Wuxi, Jiangsu, China, 214002
      • Not yet recruiting
      • Wuxi Second People's Hospital
      • Contact: Xiaoli Zhang, Principle Investigator; Phone Number: 0510-68562222; Email: zxl415@163.com
    • Zhenjiang, Jiangsu, China, 212001
      • Not yet recruiting
      • Jiangsu University Affiliated Hospital
      • Contact: Yumei Li, Principle Investigator; Phone Number: 0511-85026832; Email: l.yumei@aliyun.com
  • Jiangxi
    • Nanchang, Jiangxi, China, 330000
      • Not yet recruiting
      • Jiangxi Provincial Dermatology Hospital
      • Contact: Guohong Hu, Principle Investigator; Phone Number: 0791-85214720; Email: 20079850@qq.com
  • Shandong
    • Jinan, Shandong, China, 250011
      • Not yet recruiting
      • Shandong Provincial Hospital for Skin Diseases
      • Contact: Furen Zhang, Principle Investigator; Phone Number: 0531-87298882; Email: zhangfuren@hotmail.com
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200050
      • Not yet recruiting
      • Shanghai Dermatology Hospital
      • Contact: Yangfeng Ding; Phone Number: 021-61833000; Email: dingyangfeng@aliyun.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A -BBT001(Single Ascending Dose); A single dose of BBT001 will be administered in healthy volunteers	Drug: BBT001; BBT001 will be administered
Experimental: Part A- Placebo(Single Ascending Dose); A single dose of Placebo will be administered in healthy volunteers	Drug: Placebo; Placebo will be administered
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; BBT001 will be administered
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; Placebo will be administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration
Number of participants with change in vital sign measurements following treatment administration.	Blood pressure and heart rate will be assessed.	Part A- Up to Day 141; Part B-Up to Day 169 post first dose administration
Number of participants with change in serum blood parameters.	Laboratory assessments include hematology, blood chemistry and coagulation test	Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration
Number of participants with change in physical examination following treatment administration.	Physical examination will be assessed.	Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration
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.	Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics parameters- Time for maximum observed Concentration (Tmax)	Serum PK Tmax will be analyzed for all subjects	At specified timepoints pre-dose and up to 169 days post first dose administration
Pharmacokinetics parameters- Area under the curve (AUC)	Area under the curve of the study drug in serum will be analyzed for all subjects	At specified timepoints pre-dose and up to 169 days post first dose administration
Pharmacokinetics parameters- Volume of distribution (Vz)	Volume of distribution of the study drug in serum will be analyzed for all subjects	At specified timepoints pre-dose and up to 169 days post first dose administration
Pharmacokinetics parameters- Total clearance (CL)	Total clearance of the study drug in serum will be analyzed for all subjects	At specified timepoints pre-dose and up to 169 days post first dose administration
Pharmacokinetics parameters- - Elimination Half-life (t1/2).	Elimination half-life of the study drug in serum will be analyzed for all subjects	At specified timepoints pre-dose and up to 169 days post first dose administration
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	At specified timepoints pre-dose and up to 169 days post first dose administration
Pharmacokinetics parameters- maximum observed Concentration (Cmax)	Maximum observed concentration of the study drug in serum will be analyzed for all subjects.	At specified timepoints pre-dose and up to 169 days post first dose administration.

Collaborators and Investigators

• Sponsor: Bambusa Therapeutics
• Investigators: Study Director: Tracy Ji, Bambusa (Beijing) Therapeutics Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): March 26, 2027

Study Registration Dates

• First Submitted: September 28, 2025
• First Submitted That Met QC Criteria: November 16, 2025
• First Posted (Actual): November 20, 2025

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 16, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Dermatitis, Atopic
• Other Study ID Numbers: BBT001-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No