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A Study of BBT002 in Healthy Volunteers (HVs) and in Adult Patients With Chronic Obstructive Pulmonary Disease (COPD)

PHASE1RECRUITING

Randomized study of single and multiple doses of BBT002 in healthy volunteers and in adult patients with chronic obstructive pulmonary disease (COPD) or chronic rhinosinusitis with nasal polyps (CRSwNP).

Study details:

This study a is a randomized, double-blinded, placebo-controlled single (SAD) and multiple-ascending dose (MAD) study to evaluate safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics, and exploratory clinical activity of BBT002 in healthy volunteers (HVs) and in adult patients with COPD or CRSwNP. BBT002 is a drug candidate being developed for the treatment of COPD or CRSwNP. BBT002 will be given by intravenous injection or subcutaneous injection.

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  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
  8. Documented history of COPD with a post-bronchodilator FEV1/FVC < 0.70
  9. FEV1 ≥ 30% and FEV1<80% predicted at screening.

Exclusion criteria

  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
  9. Current diagnosis of other significant pulmonary disease
  10. Significant or unstable cardiovascular diseases
  11. Recent clinically significant infection
  12. Inability to perform spirometry

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

study type

Study type

TREATMENT

phase

Phase

    PHASE1

trial

Study ID

NCT06944925

Intervention or treatment

DRUG: BBT002

DRUG: Placebo

Conditions

  • Chronic Obstructive Pulmonary Disease

  • Condition: Chronic Obstructive Pulmonary Disease

  • DRUG: BBT002 and other drugs

  • Perth, Western Australia, Australia

  • Sponsor: Bambusa Therapeutics

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Are you running this trial?

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Research sites nearby

Closest Location:

Linear Clinical Research

Select from list below to view details:

  • Linear Clinical Research

    Perth, Western Australia, Australia

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Who is running the clinical trial?

BT

Bambusa Therapeutics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Part A: BBT002
  • A single dose of BBT002 will be administered in healthy volunteers
Drug: BBT002
    EXPERIMENTAL: Part B: BBT002
    • Multiple doses of BBT002 will be administered in healthy volunteers.
    Drug: BBT002
      EXPERIMENTAL: Part C: BBT002
      • Multiple doses of BBT002 will be administered in patients with COPD
      Drug: BBT002
        PLACEBO_COMPARATOR: Part A: Placebo
        • A single dose of Placebo will be administered in healthy volunteers.
        Drug: Placebo
          PLACEBO_COMPARATOR: Part B: Placebo
          • Multiple doses of Placebo will be administered in healthy volunteers.
          Drug: Placebo
            PLACEBO_COMPARATOR: Part C: Placebo
            • Multiple doses of Placebo will be administered in patients with COPD.
            Drug: Placebo
              PLACEBO_COMPARATOR: Part D: Placebo
              • Multiple doses of Placebo will be administered in patients with CRSwNP.
              Drug: Placebo
                PLACEBO_COMPARATOR: Part E: Placebo
                • Single dose of Placebo will be administered in healthy volunteers.
                Drug: Placebo
                  PLACEBO_COMPARATOR: Part F: Placebo
                  • Multiple doses of Placebo will be administered in patients with COPD.
                  Drug: Placebo
                    PLACEBO_COMPARATOR: Part G: Placebo
                    • Multiple doses of Placebo will be administered in patients with CRSwNP.
                    Drug: Placebo
                      EXPERIMENTAL: Part D: BBT002
                      • Multiple doses of BBT002 will be administered in patients with CRSwNP.
                      Drug: BBT002
                        EXPERIMENTAL: Part E: BBT002
                        • Single dose of BBT002 will be administered in healthy volunteers.
                        Drug: BBT002
                          EXPERIMENTAL: Part F: BBT002
                          • Multiple doses of BBT002 will be administered in patients with COPD.
                          Drug: BBT002
                            EXPERIMENTAL: Part G: BBT002
                            • Multiple doses of BBT002 will be administered in patients with CRSwNP.
                            Drug: BBT002

                              What is the study measuring?

                              Primary Outcome

                              MeasureDescriptionTime Frame
                              Number of participants with adverse events following single and multiple administration of BBT002Incidence, relatedness, and severity of adverse events (AEs) graded per CTCAE v5.0.Part A- Up to Day 141; Part B and C- Up to Day 169 post first dose administration
                              Number of participants with change in Laboratory assessmentsLaboratory assessments include hematology, coagulation, clinical chemistry and urinalysisPart A- Up to Day 141; Part B and C- Up to Day 169 post first dose administration
                              Number of participants with change in vital sign measurements following dose administration.Blood pressure and heart rate will be assessed.Part A- Up to Day 141; Part B and C- Up to Day 169 post first dose administration
                              Number of participants with change in physical examination following dose administration.Physical examination will be assessed.Part A- Up to Day 141; Part B and C- Up to Day 169 post first dose administration
                              Number of participants with change in 12-lead ECG readings12-lead ECG will be assessed.Part A- Up to Day 141; Part B and C- Up to Day 169 post first dose administration

                              Secondary Outcome

                              MeasureDescriptionTime Frame
                              PK parameters- maximum observed concentration (Cmax)Maximum observed concentration of the study drug in serum will be analyzed for all subjectsAt specified timepoints pre-dose and up to 169 days post first dose administration
                              PK parameters- Time for maximum observed Concentration (Tmax)Serum PK Tmax will be analyzed for all subjectsAt specified timepoints pre-dose and up to 169 days post first dose administration
                              PK parameters- Area under the curve (AUC)Area under the curve of the study drug in serum will be analyzed for all subjectsAt specified timepoints pre-dose and up to 169 days post first dose administration
                              PK parameters- Volume of distribution (Vz)Volume of distribution of the study drug in serum will be analyzed for all subjectsAt specified timepoints pre-dose and up to 169 days post first dose administration
                              PK parameters- Total clearance (CL)Total clearance of the study drug in serum will be analyzed for all subjectsAt specified timepoints pre-dose and up to 169 days post first dose administration
                              PK parameters- - Elimination Half-life (t1/2).Elimination half-life of the study drug in serum will be analyzed for all subjectsAt specified timepoints pre-dose and up to 169 days post first dose administration
                              The immunogenicity of BBT002 is measured as the number and percentage of subjects who develop Anti-Drug Antibodies (ADA).Serum Anti-Drug Antibodies will be analyzed for all subjectsAt specified timepoints pre-dose and up to 169 days post first dose administration
                              Are you running this trial?If you're a clinic or sponsor, you can claim this study.
                              Claim this trial

                              References

                              Clinical Trials Gov: A Study of BBT002 in Healthy Volunteers (HVs) and in Adult Patients With Chronic Obstructive Pulmonary Disease (COPD)

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