GB-0895 (SC): Multiple subcutaneous doses of GB-0895
Placebo (SC): Single subcutaneous dose of placebo
Placebo (SC): Multiple subcutaneous doses of placebo
Study summary
This study is testing the safety, tolerability, pharmacokinetics and pharmacodynamics of GB-0895.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Number of participants with treatment related adverse events as assessed by CTCAE 5.0 — Day 1 to Day 500
Trial sites (13)
Facility
City
Region
Status
Alcanza
DeLand
Florida
Miami Research Institute of South Florida
Miami
Florida
Omega Research
Orlando
Florida
Nucleus Network
Saint Paul
Minnesota
Southeastern Research Center
Winston-Salem
North Carolina
DM Clinical Research
Tomball
Texas
Charite Research Organization GmbH
Berlin
Germany
IKF Pneumologie
Frankfurt
Germany
Fraunhofer Institut fur Toxikologie and Experimentelle Medizin (ITEM)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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