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)

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

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

Treatments tested in this trial

  • BBT002
  • Placebo

Treatment groups

286 Participants
are divided into 14 treatment groups

14

Treatment groups

See each treatment group below.

Sponsors and collaborators