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

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

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

Conditions
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Idiopathic Pulmonary Fibrosis

Intervention / Treatment
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* Drug: PLN-74809
* Radiation: Knottin tracer


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Open label, incomplete crossover, up to 2 single doses administered at two different times
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PLN-74809 Dose Level 1 (60 mg)<br>PLN-74809 Dose Level 1 (60mg) | Drug: PLN-74809<br>* PLN-74809<br>Radiation: Knottin tracer<br>* Radiotracer<br>|
| Experimental: PLN-74809 Dose Level 2 (80 mg)<br>PLN-74809 Dose Level 2 (80 mg) | Drug: PLN-74809<br>* PLN-74809<br>Radiation: Knottin tracer<br>* Radiotracer<br>|
| Experimental: PLN-74809 Dose Level 3 (120 mg)<br>PLN-74809 Dose Level 3 (120 mg) | Drug: PLN-74809<br>* PLN-74809<br>Radiation: Knottin tracer<br>* Radiotracer<br>|
| Experimental: PLN-74809 Dose Level 4 (240 mg)<br>PLN-74809 Dose Level 4 (240 mg) | Drug: PLN-74809<br>* PLN-74809<br>Radiation: Knottin tracer<br>* Radiotracer<br>|
| Experimental: PLN-74809 Dose Level 4 (320 mg)<br>PLN-74809 Dose Level 4 (320 mg) | Drug: PLN-74809<br>* PLN-74809<br>Radiation: Knottin tracer<br>* Radiotracer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With a Predicted Effect on αVβ6 PET ( Positron Emission Tomography) in Lungs After Administration of Drug. | 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. | Following 1 day of dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability of PLN-74809 as Measured by the Number / Percentage of Adverse Events | Adverse events were collected from the time the participant signs the Informed Consent Form until the last day of visit (Day 14). | From screening to 1 week following the administration of PLN-74809 |