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Phase 2a Evaluation of PLN-74809 on αvβ6 Receptor Occupancy Using PET Imaging in Participants With IPF/
Not Recruiting
Trial ID: NCT04072315
Purpose
A study in mild/moderate IPF patients using an αVβ6 PET ligand to evaluate target engagement.
Official Title
A Phase 2a Evaluation of PLN-74809 on αvβ6 Receptor Occupancy Using PET Imaging in Participants With IPF
Stanford Investigator(s)
Joshua Mooney
Clinical Assistant Professor, Medicine - Pulmonary, Allergy & Critical Care Medicine
Eligibility
Inclusion Criteria:
* Diagnosis of IPF, within 5 years prior to Screening,
* FVC %predicted ≥45%; historical FVC for entry in the study is permitted if within 1 month of screening.
* DLco (hemoglobin-adjusted) ≥30%; historical DLco for entry in the study is permitted if within 1 month of screening.
* Participants receiving treatment for IPF with nintedanib or pirfenidone are allowed,if on a stable dose for at least 3 months
Exclusion Criteria:
* Currently receiving or planning to initiate treatment for IPF (fibrosis) with agents not approved for that indication by the FDA
* Forced expiratory volume during the first seconds of the forced breath (FEV1)/FVC ratio \<0.7
* Clinical evidence of active infection, including but not limited to bronchitis, pneumonia, sinusitis that can affect FVC measurement or IPF progression
* Known acute IPF exacerbation or suspicion by the Investigator of such, within 6 months of Screening
* Smoking of any kind within 3 months of Screening
Intervention(s):
drug: PLN-74809
radiation: Knottin tracer
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Joshua Mooney, MD