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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06944925




Registration number
NCT06944925
Ethics application status
Date submitted
18/04/2025
Date registered
25/04/2025
Date last updated
14/05/2025

Titles & IDs
Public title
A Study of BBT002 in Healthy Volunteers (HVs) and in Adult Patients With Chronic Obstructive Pulmonary Disease (COPD)
Scientific title
A Randomized, Blinded, Placebo-controlled, Single- and Multiple-ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics and Clinical Activity of BBT002 in HVs and COPD Patients
Secondary ID [1] 0 0
BBT002-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BBT002
Treatment: Drugs - Placebo

Experimental: Part A Single Ascending Dose BBT002 - A single dose of BBT002 will be administered in healthy volunteers

Experimental: Part B Multiple Ascending Dose BBT002 - Three doses of BBT002 will be administered in healthy volunteers.

Experimental: Part C Multiple Ascending Dose BBT002 - Two doses of BBT002 will be administered in patients with COPD.

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 - Two doses of Placebo will be administered in patients with COPD.


Treatment: Drugs: BBT002
BBT002 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 BBT002
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 Laboratory assessments
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 dose 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 dose administration.
Timepoint [4] 0 0
Part A- Up to Day 141; Part B and C- Up to Day 169 post first dose administration
Primary outcome [5] 0 0
Number of participants with change in 12-lead ECG readings
Timepoint [5] 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
PK 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
PK 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
PK 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
PK 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
PK 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
PK 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 BBT002 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 (Parts A, B, C)

1. Age of 18-65 years (HVs), 35-75 years (patients)
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. Documented history of COPD with a post-bronchodilator FEV1/FVC < 0.70
2. FEV1 = 30% and FEV1<80% predicted at screening.

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

1. Positive viral serology for human immunodeficiency virus (HlV), hepatitis C virus (HCV), or hepatitis B (HBV)
2. Immunodeficiencies, autoimmune diseases, or cancer, history of conditions predisposing to infections
3. History of major metabolic, dermatological, liver, kidney, hematological or other significant disorders
4. Clinically relevant abnormal lab results, including low blood counts, liver enzymes, or abnormal kidney function
5. Positive drug/alcohol tests or abnormal vital signs at screening or Day -1
6. Abnormal Electrocardiogram(ECG) findings
7. History of drug/alcohol abuse in the past 2 years
8. History of severe allergic reactions or hypersensitivity

Key Exclusion Criteria for (Part C only)

1. Current diagnosis of other significant pulmonary disease
2. Significant or unstable cardiovascular diseases
3. Recent clinically significant infection
4. Inability to perform spirometry

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
8/05/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/03/2027
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

No information has been provided regarding IPD availability


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/NCT06944925