A Phase I/II Study to Evaluate the Safety, Pharmacokinetics, and Clinical Activity of BBT002 in Healthy Volunteers and Patients with COPD, CRSwNP, or Comorbid Asthma

The primary objective is to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics, and clinical activity of BBT002 in healthy volunteers and patients diagnosed with chronic obstructive pulmonary disease, chronic rhinosinusitis with nasal polyps, or comorbid asthma. This assessment is essential to characterize the pharmacological profile and therapeutic potential of the investigational product within these respiratory populations.

• Safety and tolerability
• Pharmacokinetics
• Immunogenicity
• Pharmacodynamics
• Clinical activity

This clinical trial involves a total of 98 patients. The study population includes both male and female participants within the 3 to 12 years age range. The subjects are characterized by the presence of chronic obstructive pulmonary disease, chronic rhinosinusitis with nasal polyps, and comorbid asthma.

This Phase 1 clinical trial is designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics, and clinical activity of BBT002. The study involves healthy volunteers and patients diagnosed with chronic obstructive pulmonary disease, chronic rhinosinusitis with nasal polyps, or comorbid asthma. The research methodology encompasses various study visits, beginning with a screening visit to assess eligibility. Subsequent follow-up visits are conducted to monitor physiological responses and clinical parameters, concluding with an end-of-study visit. Participation duration is determined by the specific protocol requirements for each subject. Early termination from the study may occur based on predefined clinical criteria or safety considerations.

The assessment of efficacy in this clinical trial focuses on patients diagnosed with Chronic Obstructive Pulmonary Disease, Chronic Rhinosinusitis with Nasal Polyps, and comorbid asthma.