FDL176 / Flatley Discovery Lab - LARVOL DELTA

Safety, tolerability and pharmacokinetics of the CFTR potentiator FDL176 (ECFS Belgrade 2018) - "In combination with CFTR corrector FDL169, it has similar in vitro efficacy to lumacaftor/ivacaftor under acute conditions and higher under chronic conditions. FDL176 is well tolerated and demonstrated a favorable safety profile in healthy subjects. Safety and PK profile support further development of FDL176."

Clinical • PK/PD data • Biosimilar • Dermatology • Immunology

A DDI Study of FDL169 and FDL176 in Healthy Subjects (clinicaltrials.gov) - P1/2; N=78; Suspended; Sponsor: Flatley Discovery Lab LLC; Recruiting ➔ Suspended

Clinical • Trial suspension

A DDI Study of FDL169 and FDL176 in Healthy Subjects (clinicaltrials.gov) - P1/2; N=78; Recruiting; Sponsor: Flatley Discovery Lab LLC; Phase classification: P1 ➔ P1/2; N=32 ➔ 78; Trial completion date: Mar 2019 ➔ Feb 2020; Trial primary completion date: Mar 2019 ➔ Feb 2020

Clinical • Enrollment change • Phase classification • Trial completion date • Trial primary completion date