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

Overview

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

Full Title of Study: “A Phase 2a Evaluation of PLN-74809 on αvβ6 Receptor Occupancy Using PET Imaging in Participants With IPF”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 27, 2022

Interventions

  • Drug: PLN-74809
    • PLN-74809
  • Radiation: Knottin tracer
    • Radiotracer

Arms, Groups and Cohorts

  • Experimental: PLN-74809 Dose Level 1 (60 mg)
    • PLN-74809 Dose Level 1 (60mg)
  • Experimental: PLN-74809 Dose Level 2 (80 mg)
    • PLN-74809 Dose Level 2 (80 mg)
  • Experimental: PLN-74809 Dose Level 3 (120 mg)
    • PLN-74809 Dose Level 3 (120 mg)
  • Experimental: PLN-74809 Dose Level 4 (240 mg)
    • PLN-74809 Dose Level 4 (240 mg)
  • Experimental: PLN-74809 Dose Level 4 (320 mg)
    • PLN-74809 Dose Level 4 (320 mg)

Clinical Trial Outcome Measures

Primary Measures

  • Number of Participants With a Predicted Effect on αVβ6 PET ( Positron Emission Tomography) in Lungs After Administration of Drug.
    • Time Frame: 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 Measures

  • Safety and Tolerability of PLN-74809 as Measured by the Number / Percentage of Adverse Events
    • Time Frame: From 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).

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Pliant Therapeutics, Inc.
  • Collaborator
    • Stanford University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Pliant Therapeutics Medical Monitor, Study Director, Pliant Therapeutics, Inc.

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