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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	40 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04072315
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Pliant Therapeutics, Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Pliant Therapeutics Medical Monitor
Principal Investigator Affiliation	Pliant Therapeutics, Inc.
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry, Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Idiopathic Pulmonary Fibrosis

Arms & Interventions

Arms

Experimental: PLN-74809 Dose Level 1

PLN-74809 Dose Level 1

Experimental: PLN-74809 Dose Level 2

PLN-74809 Dose Level 2

Experimental: PLN-74809 Dose Level 3

PLN-74809 Dose Level 3

Experimental: PLN-74809 Dose Level 4

PLN-74809 Dose Level 4

Interventions

Drug: - PLN-74809

PLN-74809

Radiation: - Knottin tracer

Radiotracer

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Stanford Medical Center, Palo Alto, California

Status

Recruiting

Address

Stanford Medical Center

Palo Alto, California, 94305

Site Contact

Joshua Mooney, MD

clintrials@pliantrx.com