A Study of BBT002 in Healthy Volunteers (HVs) and in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBambusa Therapeutics
About this trial
This study is a randomized, double-Blind, placebo-controlled, Single- and Multiple-ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics and Clinical Activity of BBT002 in Healthy Volunteers and Participants with Chronic Obstructive Pulmonary Disease (COPD).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age of 18-65 years (HVs), 35-75 years (patients)
Body mass index between 18-32 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
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
DrugBBT002 will be administered
Placebo
DrugPlacebo will be administered
Treatment groups
68 Participants
are divided into 4 treatment groupsGroup A: Part A Single Ascending Dose BBT002Experimental treatment 1 intervention
Group B: Part B Multiple Ascending Dose BBT002Experimental treatment 1 intervention
Group C: Part A Single Ascending Dose PlaceboPlacebo comparator 1 intervention
Group D: Part B Multiple Ascending Dose PlaceboPlacebo comparator 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 v5.0.
Time frame
Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration2
Number of participants with change in Laboratory assessments
Laboratory assessments include hematology, coagulation, clinical chemistry and urinalysis
Time frame
Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration3
Number of participants with change in vital sign measurements following dose administration.
Blood pressure and heart rate will be assessed.
Time frame
Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration4
Number of participants with change in physical examination following dose administration.
Physical examination will be assessed.
Time frame
Part A- Up to Day 141; Part B - Up to Day 169 post first dose administrationSecondary 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 administration2
PK parameters- Time for 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 administration3
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 administration4
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 administrationSponsors and contacts
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Source ClinicalTrials.gov