A Study to Investigate GB-0895 in Adults With Mild to Moderate Asthma or COPD

A Phase 1 First in Human, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of GB-0895 in Adults With Mild to Moderate Asthma or Single Dose in Chronic Obstructive Pulmonary Disease (COPD)

This study is testing the safety, tolerability, pharmacokinetics and pharmacodynamics of GB-0895.

Inclusion Criteria (Part A & B, Asthma):

• Participants must be able to give written consent
• 18 to 65 years of age (inclusive) at the screening visit;
• Diagnoses of mild to moderate asthma for ≥12 months
• Laboratory blood values within the ranges outlined in the protocol

Exclusion Criteria (Part A & B, Asthma):

• Other serious disease
• Significant asthma exacerbations
• Current smokers or ex-smokers with >5 pack years smoking history
• Pregnant or breastfeeding

Inclusion Criteria (Part C, COPD):

• Participants must be able to give written consent
• 40 to 80 years of age (inclusive) at the screening visit;
• Diagnoses of COPD for ≥12 months
• Laboratory blood values within the ranges outlined in the protocol
• Must be current or ex-smoker

Exclusion Criteria (Part C, COPD):

• Other serious disease
• COPD exacerbation within 4 weeks of enrolling
• Requires supplemental oxygen (CPAP for sleep apnea allowed)
• Pregnant or breastfeeding