A Phase 2 Study to Evaluate Safety and Efficacy of AMB-05X in Subjects With Idiopathic Pulmonary Fibrosis
Megadott ok: to focus resources on other studies
Key facts
- Phase
- 2. fázis
Trial details
- Who runs it
- AmMax Bio, Inc.
- Trial code
- NCT05349760
- Record updated
- 2023. január 19.
- Original description
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.Read full original descriptionShow less
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: Subjects ≥40 years old; History of confirmed diagnosis of IPF; Chest HRCT at Screening; 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); Has FVC ≥45% predicted of normal AND DLCO ≥25% and ≤90% predicted; Has a FEV1/FVC ratio (Tiffeneau-Pinelli Index) ≥ 0.70; Has adequate hematologic, hepatic, and renal function.
Exclusion: Prior investigational drug use within 30 days or 5 half-lives; Active or anticipated need for lung transplant; Treatment with prednisone; Active cancer; Active or chronic infection with HCV, HBV, or HIV; Known active tuberculosis; History of or current immunosuppressive condition; Lower respiratory-tract infection requiring antibiotic therapy; Other forms of interstitial lung disease; History of lung volume reduction surgery or lung transplant; Unstable cardiac or pulmonary disease (other than IPF); History of drug or alcohol abuse -; Fridericia-corrected QT interval (QTcF) ≥ 450 ms (men) or ≥ 470 ms (women); Presence of emphysema exceeding the extent of fibrosis; IPF exacerbation within 12 weeks; Smoking; Contraindications for forced expiratory maneuvers during spirometry.