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A Study of BBT002 in Healthy Volunteers (HVs) and in Adult Patients With Chronic Obstructive Pulmonary Disease (COPD) or Chronic Rhiosininusitis With Nasal Polyps (CRSwNP)

ConditionChronic Obstructive Pulmonary Disease
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorBambusa Therapeutics

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age 18-65 years for HVs (Parts A, B, and E); age 35-80 years for patients with COPD (Parts C and F,); age 18-80 for patients with CRSwNP (Parts D and G)

Body mass index between 18.0-32.0 kg/m square, capped weight at 120kg, for HVs (Parts A, B, and E); body mass index between 16.0-35.0 kg/m square, capped weight at 125kg for patients (Parts C, D, F, and G)

Negative pregnancy tests for women of childbearing potential

Willingness to refrain from alcohol consumption for 24 hours prior to each study visit

Disqualifiers

Positive viral serology for human immunodeficiency virus (HlV), hepatitis C virus (HCV), or hepatitis B (HBV)

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 enzymes, or abnormal kidney function

Trial design

Design model

Sequential

Treatments tested in this trial

  • BBT002

    Drug

    BBT002 will be administered.

  • Placebo

    Drug

    Placebo will be administered.

Treatment groups

286 Participants
are divided into 14 treatment groups

14

Treatment groups

See each treatment group below.

Group A: Part A: BBT002Experimental treatment 1 intervention
Group B: Part B: BBT002Experimental treatment 1 intervention
Group C: Part C: BBT002Experimental treatment 1 intervention
Group D: Part A: PlaceboPlacebo comparator 1 intervention
Group E: Part B: PlaceboPlacebo comparator 1 intervention
Group F: Part C: PlaceboPlacebo comparator 1 intervention
Group G: Part D: PlaceboPlacebo comparator 1 intervention
Group H: Part E: PlaceboPlacebo comparator 1 intervention
Group I: Part F: PlaceboPlacebo comparator 1 intervention
Group J: Part G: PlaceboPlacebo comparator 1 intervention
Group K: Part D: BBT002Experimental treatment 1 intervention
Group L: Part E: BBT002Experimental treatment 1 intervention
Group M: Part F: BBT002Experimental treatment 1 intervention
Group N: Part G: BBT002Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with adverse events following single and multiple administration of BBT002

Incidence, relatedness, and severity of adverse events (AEs) graded per CTCAE v6.0.

Time frame
Parts A and E - up to 141 days post first dose administration; Parts B, C, D, F, and G - up to 169 days post first dose administration
2

Number of participants with change in Laboratory assessments

Laboratory assessments include hematology, coagulation, clinical chemistry and urinalysis

Time frame
Parts A and E - up to 141 days post first dose administration; Parts B, C, D, F, and G - up to 169 days post first dose administration
3

Number of participants with change in vital sign measurements following dose administration.

Blood pressure and heart rate will be assessed.

Time frame
Parts A and E - up to 141 days post first dose administration; Parts B, C, D, F, and G - up to 169 days post first dose administration
4

Number of participants with change in physical examination following dose administration.

Physical examination will be assessed.

Time frame
Parts A and E - up to 141 days post first dose administration; Parts B, C, D, F, and G - up to 169 days post first dose administration

Secondary outcomes

1

PK parameters- maximum observed concentration (Cmax)

Maximum observed concentration of the study drug in serum will be analyzed for all subjects

Time frame
At specified timepoints pre-dose and up to 169 days post first dose administration
2

PK parameters- Time of maximum observed Concentration (Tmax)

Serum PK Tmax will be analyzed for all subjects

Time frame
At specified timepoints pre-dose and up to 169 days post first dose administration
3

PK parameters- Area under the curve (AUC)

Area under the curve of the study drug in serum will be analyzed for all subjects

Time frame
At specified timepoints pre-dose and up to 169 days post first dose administration
4

PK parameters- Volume of distribution (Vz)

Volume of distribution of the study drug in serum will be analyzed for all subjects

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bambusa Therapeutics

Lead sponsor

Source ClinicalTrials.gov
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