MedPath

Phase 2a Evaluation of PLN-74809 on αvβ6 Receptor Occupancy Using PET Imaging in Participants With IPF/

Phase 2
Completed
Conditions
Idiopathic Pulmonary Fibrosis
Interventions
Drug: PLN-74809
Radiation: Knottin tracer
Registration Number
NCT04072315
Lead Sponsor
Pliant Therapeutics, Inc.
Brief Summary

A study in mild/moderate IPF patients using an αVβ6 PET ligand to evaluate target engagement.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
9
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
Read More
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
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
PLN-74809 Dose Level 2 (80 mg)Knottin tracerPLN-74809 Dose Level 2 (80 mg)
PLN-74809 Dose Level 3 (120 mg)PLN-74809PLN-74809 Dose Level 3 (120 mg)
PLN-74809 Dose Level 1 (60 mg)PLN-74809PLN-74809 Dose Level 1 (60mg)
PLN-74809 Dose Level 1 (60 mg)Knottin tracerPLN-74809 Dose Level 1 (60mg)
PLN-74809 Dose Level 3 (120 mg)Knottin tracerPLN-74809 Dose Level 3 (120 mg)
PLN-74809 Dose Level 4 (320 mg)Knottin tracerPLN-74809 Dose Level 4 (320 mg)
PLN-74809 Dose Level 4 (240 mg)Knottin tracerPLN-74809 Dose Level 4 (240 mg)
PLN-74809 Dose Level 2 (80 mg)PLN-74809PLN-74809 Dose Level 2 (80 mg)
PLN-74809 Dose Level 4 (240 mg)PLN-74809PLN-74809 Dose Level 4 (240 mg)
PLN-74809 Dose Level 4 (320 mg)PLN-74809PLN-74809 Dose Level 4 (320 mg)
Primary Outcome Measures
NameTimeMethod
Number of Participants With a Predicted Effect on αVβ6 PET ( Positron Emission Tomography) in Lungs After Administration of Drug.Following 1 day of dosing

Assessment of the primary endpoint was made using standard methods for quantifying the amount to PET tracer bound to the αvβ6 integrin receptor in the lungs before and after administration of study drug and PK/PD modeling.

Secondary Outcome Measures
NameTimeMethod
Safety and Tolerability of PLN-74809 as Measured by the Number / Percentage of Adverse EventsFrom screening to 1 week following the administration of PLN-74809

Adverse events were collected from the time the participant signs the Informed Consent Form until the last day of visit (Day 14).

Trial Locations

Locations (1)

Stanford Medical Center

🇺🇸

Palo Alto, California, United States

© Copyright 2025. All Rights Reserved by MedPath