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
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