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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06808477




Registration number
NCT06808477
Ethics application status
Date submitted
30/01/2025
Date registered
5/02/2025
Date last updated
4/03/2025

Titles & IDs
Public title
A Study of BBT001 in Healthy Volunteers (HVs) and in Adult Patients With Atopic Dermatitis (AD)
Scientific 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 Patients
Secondary ID [1] 0 0
BBT001-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BBT001
Treatment: Drugs - Placebo

Experimental: Part A Single Ascending Dose BBT001 - A single dose of BBT001 will be administered in healthy volunteers

Experimental: Part B Multiple Ascending Dose BBT001 - Three doses of BBT001 will be administered in healthy volunteers.

Experimental: Part C Multiple Ascending Dose BBT001 - Three doses of BBT001 will be administered in patients with atopic dermatitis.

Placebo comparator: Part A Single Ascending Dose Placebo - A single dose of Placebo will be administered in healthy volunteers

Placebo comparator: Part B Multiple Ascending Dose Placebo - Three doses of Placebo will be administered in healthy volunteers.

Placebo comparator: Part C Multiple Ascending Dose Placebo - Three doses of Placebo will be administered in patients with atopic dermatitis.


Treatment: Drugs: BBT001
BBT001 will be administered

Treatment: Drugs: Placebo
Placebo will be administered
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with adverse events following single and multiple administration of BBT001
Timepoint [1] 0 0
Part A- Up to Day 141; Part B and C- Up to Day 169 post first dose administration
Primary outcome [2] 0 0
Number of participants with change in serum blood parameters
Timepoint [2] 0 0
Part A- Up to Day 141; Part B and C- Up to Day 169 post first dose administration
Primary outcome [3] 0 0
Number of participants with change in vital sign measurements following treatment administration.
Timepoint [3] 0 0
Part A- Up to Day 141; Part B and C- Up to Day 169 post first dose administration
Primary outcome [4] 0 0
Number of participants with change in physical examination following treatment administration.
Timepoint [4] 0 0
Part A- Up to Day 141; Part B and C- Up to Day 169 post first dose administration
Secondary outcome [1] 0 0
Pharmacokinetics parameters- maximum observed Concentration (Cmax)
Timepoint [1] 0 0
At specified timepoints pre-dose and up to 169 days post first dose administration
Secondary outcome [2] 0 0
Pharmacokinetics parameters- Time for maximum observed Concentration (Tmax)
Timepoint [2] 0 0
At specified timepoints pre-dose and up to 169 days post first dose administration
Secondary outcome [3] 0 0
Pharmacokinetics parameters- Area under the curve (AUC)
Timepoint [3] 0 0
At specified timepoints pre-dose and up to 169 days post first dose administration
Secondary outcome [4] 0 0
Pharmacokinetics parameters- Volume of distribution (Vz)
Timepoint [4] 0 0
At specified timepoints pre-dose and up to 169 days post first dose administration
Secondary outcome [5] 0 0
Pharmacokinetics parameters- Total clearance (CL)
Timepoint [5] 0 0
At specified timepoints pre-dose and up to 169 days post first dose administration
Secondary outcome [6] 0 0
Pharmacokinetics parameters- - Elimination Half-life (t1/2).
Timepoint [6] 0 0
At specified timepoints pre-dose and up to 169 days post first dose administration
Secondary outcome [7] 0 0
The immunogenicity of BBT001 is measured as the number and percentage of subjects who develop Anti-Drug Antibodies (ADA).
Timepoint [7] 0 0
At specified timepoints pre-dose and up to 169 days post first dose administration

Eligibility
Key inclusion criteria
Key Inclusion Criteria (Part A, B, C)

1. Age of 18-65 years.
2. Body mass index between 18-32 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 C 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.

Key
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion Criteria for (Part A, B, C)

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 C 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 design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/02/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
6/02/2027
Actual
Sample size
Target
98
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Linear Clinical Research - Perth
Recruitment postcode(s) [1] 0 0
6009 - Perth

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bambusa Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Lisa Li
Address 0 0
Bambusa Therapeutics, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Lisa Li
Address 0 0
Country 0 0
Phone 0 0
+1 858 353 4948
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06808477