A Study to Investigate GB-0895 in Adults With Mild to Moderate Asthma or COPD (NCT07116889) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study to Investigate GB-0895 in Adults With Mild to Moderate Asthma or COPD
United States156 participantsStarted 2023-12-12
Plain-language summary
This study is testing the safety, tolerability, pharmacokinetics and pharmacodynamics of GB-0895.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Number of participants with treatment related adverse events as assessed by CTCAE 5.0