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Recruiting
NCT07730281
PRA-216 COPD Safety and Biomarker Study
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Sex: All
Ages: 40 Years – 80 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 40
Sponsor: Prana Therapies Inc
Location: Emeritus Research Sydney Botany New South Wales
Summary
This study will evaluate the safety, tolerability, pharmacokinetics and immunogenicity of PRA-216 compared to placebo in patients with chronic obstructive pulmonary disease (COPD).
Eligibility Criteria
Inclusion Criteria:
* Age 40-80
* Willing and able to attend all study visits, comply with study requirements.
* Able and willing to provide written informed consent
* Documented COPD diagnosis prior for at least 12 months prior to screening.
* Currently receiving maintenance COPD medications at a stable dose for at least 3 months prior to visit 1
Exclusion Criteria:
* Evidence of clinically significant pulmonary condition or disease other than COPD
* Any physical or psychological condition that prohibits study completion
* Known history of illicit drug use or alcoholism within 12 months prior to the first dose of study agent
* History of severe allergic reactions or hypersensitivity
* Major surgery occurring within 8 weeks months prior to first dose of investigational product.
* Use of any marketed or investigational monoclonal or polyclonal antibody therapy within 4 months or 5 half-lives prior to visit 1.
Source: ClinicalTrials.gov (NCT07730281). StuddyBuddy aggregates publicly available trial information.