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

NCT07239947 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: BBT001-002
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 10

Brief 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).

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (7)

• Pharmacokinetics parameters- maximum observed Concentration (Cmax)

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

• Pharmacokinetics parameters- Time for maximum observed Concentration (Tmax)

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

• Pharmacokinetics parameters- Area under the curve (AUC)

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

• Pharmacokinetics parameters- Volume of distribution (Vz)

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

• Pharmacokinetics parameters- Total clearance (CL)

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

Study Arms (4)

Part A -BBT001(Single Ascending Dose)

EXPERIMENTAL

A single dose of BBT001 will be administered in healthy volunteers

Drug: BBT001

Part A- Placebo(Single Ascending Dose)

EXPERIMENTAL

A single dose of Placebo will be administered in healthy volunteers

Drug: Placebo

Part B- BBT001(Multiple Ascending Dose)

EXPERIMENTAL

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

Drug: BBT001

Part B -Placebo (Multiple Ascending Dose))

EXPERIMENTAL

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

Drug: Placebo

Interventions

BBT001 DRUG

BBT001 will be administered

Part A -BBT001(Single Ascending Dose); Part B- BBT001(Multiple Ascending Dose)

Placebo DRUG

Placebo will be administered

Part A- Placebo(Single Ascending Dose); Part B -Placebo (Multiple Ascending Dose))

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of 18-65 years.
• Body mass index between 18-28 kg/m², capped at 120 kg.
• Negative pregnancy tests for women of childbearing potential.
• Willingness to refrain from alcohol consumption for 24 hours prior to each study visit.
• Non-smokers, healthy current smokers (≤5 cigarettes/day), or ex-smokers.
• Adequate contraception use (for men and women of childbearing potential).
• No clinically significant abnormalities or history of relevant diseases.
• Must have dermatologist-confirmed chronic atopic dermatitis (≥12 months). Inadequate response to topical treatments or where they are medically inadvisable.
• Moderate to severe atopic dermatitis
• Validated investigator's global assessment for atopic dermatitis (vIGA-ADTM) score ≥3
• Atopic lesions cover ≥10% of body surface area (BSA)
• Average peak pruritus numeric rating scale (PP-NRS) score ≥4 in the 7 days before randomization.
• Eczema Area and Severity Index (EASI) score ≥16 at screening and randomization visits.

You may not qualify if:

• 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.
• History of major metabolic, dermatological, liver, kidney, hematological, or other significant disorders.
• Clinically relevant abnormal lab results, including low blood counts, liver issues, or abnormal kidney function.
• Positive drug/alcohol tests or abnormal vital signs at screening or Day -1.
• Abnormal Electrocardiogram (ECG) findings
• History of drug/alcohol abuse in the past 2 years.
• Donated \>500mL blood within 2 months of screening.
• History of severe allergic reactions or hypersensitivity.
• Skin diseases other than atopic dermatitis, significant tattoos, or scarring.
• Receipt of immunoglobulin or blood products within 30 days.
• Atopic dermatitis with ocular symptoms or chronic ocular steroid use.
• Chronic pruritus from conditions other than atopic dermatitis.
• Acute/treated infections or chronic skin infections.
• Current use of sedating antihistamines or corticosteroids.

Sponsors & Collaborators

• Bambusa Therapeutics: lead

Study Sites (10)

The Second Hospital of Anhui Medical Univesity

Hefei, Anhui, 230601, China

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

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

NOT YET RECRUITING

Jiangsu University Affiliated Hospital

Zhenjiang, Jiangsu, 212001, China

NOT YET RECRUITING

Jiangxi Provincial Dermatology Hospital

Nanchang, Jiangxi, 330000, China

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

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Tracy Ji

  Bambusa (Beijing) Therapeutics Co., Ltd.

  STUDY DIRECTOR

Central Study Contacts

Tracy Ji

CONTACT

+86 18001322760; tracy.ji@bambusatx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2025
• First Posted: November 20, 2025
• Study Start: August 9, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): March 26, 2027
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (10)