A Phase 2 Study to Evaluate Safety and Efficacy of AMB-05X in Subjects With Idiopathic Pulmonary Fibrosis

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of AMB-05X in Subjects With Idiopathic Pulmonary Fibrosis

AMB-053-01 is a randomized, placebo controlled, multicenter study which will enroll approximately 36 subjects ages 40 and older with IPF for 6 doses over a 24-week dosing period.

Inclusion Criteria:

1. Subjects ≥40 years old.

2. History of confirmed diagnosis of IPF

3. Chest HRCT at Screening

4. Subjects who are either:

   • Not being treated with approved IPF therapies (i.e., nintedanib or pirfenidone) or
   • Being treated with approved IPF therapies (i.e., nintedanib or pirfenidone)

5. Has FVC ≥45% predicted of normal AND DLCO ≥25% and ≤90% predicted

6. Has a FEV1/FVC ratio (Tiffeneau-Pinelli Index) ≥ 0.70

7. Has adequate hematologic, hepatic, and renal function

Exclusion Criteria:

1. Prior investigational drug use within 30 days or 5 half-lives
2. Presence of emphysema exceeding the extent of fibrosis
3. Active or anticipated need for lung transplant
4. Treatment with prednisone
5. Active cancer
6. Active or chronic infection with HCV, HBV, or HIV
7. Known active tuberculosis
8. History of or current immunosuppressive condition
9. IPF exacerbation within 12 weeks
10. Lower respiratory-tract infection requiring antibiotic therapy
11. Smoking
12. Other forms of interstitial lung disease
13. History of lung volume reduction surgery or lung transplant
14. Contraindications for forced expiratory maneuvers during spirometry
15. Unstable cardiac or pulmonary disease (other than IPF)
16. Fridericia-corrected QT interval (QTcF) ≥ 450 ms (men) or ≥ 470 ms (women)
17. History of drug or alcohol abuse -