A Phase 2 Study to Evaluate the Safety, Biological Activity, and PK of ND-L02-s0201 in Subjects With IPF

Inclusion Criteria:

- Forced vital capacity (FVC) ≥ 45% of predicted.

- Diffusion capacity of the lung for carbon monoxide (DLco) corrected for hemoglobin ≥
30% of predicted value

- Ratio of forced expiratory volume in 1 second (FEV1) to FVC ≥ 0.70.

Exclusion Criteria:

- Best, acceptable FVC from separate screening spirometry that differ by ≥ 200 mL.

- Respiratory exacerbation(s) or hospitalization for IPF exacerbation within 3 months
before screening.

- Anticipated to receive a lung transplant during the subject's participation in the
study.

- Active smoker or smoking cessation within 12 weeks before screening.

- Malignancy within the last 5 years, with the exception of curable cancer that has
received adequate treatment.

- Evidence of any unstable or untreated, clinically significant disease or condition
that, in the opinion of the Investigator, might confound the interpretation of the
study or place the subject at increased risk.

- Treatment with high dose corticosteroids, cytotoxic agents, unapproved IPF targeted
therapy, and cytokine modulating agents within 8 weeks or 5 half-lives (whichever is
longer) before screening

- Participation in an investigational study with the last dose of investigational
product occurring within 8 weeks or 5 half-lives (whichever is longer) before
screening.

- Pregnant or breastfeeding.

- Medical history of infection with HIV, hepatitis B, or hepatitis C.

- History of alcohol abuse and/or dependence within the last 2 years.

- History within the last 2 years of significant mental illness, or physical dependence
on any opioid or illicit drugs.

Other protocol defined inclusion/exclusion criteria could apply.