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Recruiting NCT07239947

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

Phase I Interventional Atopic Dermatitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BBT001, Placebo.
Who it may be relevant to
Registry conditions: Atopic Dermatitis. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

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)

Interventions

  • Drug BBT001
    BBT001 will be administered
  • Drug Placebo
    Placebo will be administered

Primary outcome measures

  • Number of participants with adverse events following single and multiple administration of BBT001 [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration]
Secondary outcome measures (7)
  • Pharmacokinetics parameters- maximum observed Concentration (Cmax) [Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration.]
  • Pharmacokinetics parameters- Time for maximum observed Concentration (Tmax) [Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration]
  • Pharmacokinetics parameters- Area under the curve (AUC) [Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration]
  • Pharmacokinetics parameters- Volume of distribution (Vz) [Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration]
  • Pharmacokinetics parameters- Total clearance (CL) [Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration]
  • Pharmacokinetics parameters- - Elimination Half-life (t1/2). [Time frame: 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). [Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration]

Eligibility criteria

Key Inclusion Criteria ( Part A and B):

  • 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.

Key Inclusion Criteria (Part B only):

  • 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.
  • （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)

  • 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.

Key Exclusion Criteria for (Part B only)

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Sequential
Masking
Triple blind
Primary purpose
Treatment

Study locations

China · 10 centers
  • The Second Hospital of Anhui Medical Univesity — Hefei
  • The Second Affiliated Hospital of Wannan Medical College — Wuhu
  • Peking University People's Hospital — Beijing
  • Dermatology Hospital of Southern Medical University — Guangzhou
  • The Second Xiangya Hospital of Central South University — Changsha
  • Wuxi Second People's Hospital — Wuxi
  • Jiangsu University Affiliated Hospital — Zhenjiang
  • Jiangxi Provincial Dermatology Hospital — Nanchang
  • … and 2 more centers

Identifiers

NCT: NCT07239947 · BBT001-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗