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-74809Radiation: 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
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description PLN-74809 Dose Level 2 (80 mg) Knottin tracer PLN-74809 Dose Level 2 (80 mg) PLN-74809 Dose Level 3 (120 mg) PLN-74809 PLN-74809 Dose Level 3 (120 mg) PLN-74809 Dose Level 1 (60 mg) PLN-74809 PLN-74809 Dose Level 1 (60mg) PLN-74809 Dose Level 1 (60 mg) Knottin tracer PLN-74809 Dose Level 1 (60mg) PLN-74809 Dose Level 3 (120 mg) Knottin tracer PLN-74809 Dose Level 3 (120 mg) PLN-74809 Dose Level 4 (320 mg) Knottin tracer PLN-74809 Dose Level 4 (320 mg) PLN-74809 Dose Level 4 (240 mg) Knottin tracer PLN-74809 Dose Level 4 (240 mg) PLN-74809 Dose Level 2 (80 mg) PLN-74809 PLN-74809 Dose Level 2 (80 mg) PLN-74809 Dose Level 4 (240 mg) PLN-74809 PLN-74809 Dose Level 4 (240 mg) PLN-74809 Dose Level 4 (320 mg) PLN-74809 PLN-74809 Dose Level 4 (320 mg)
- Primary Outcome Measures
Name Time Method 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
Name Time Method Safety and Tolerability of PLN-74809 as Measured by the Number / Percentage of Adverse Events 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).
Trial Locations
- Locations (1)
Stanford Medical Center
🇺🇸Palo Alto, California, United States