A First-In-Human Study to Investigate FDL169 in Healthy Volunteers

• Research type

  Research Study

• Full title

  A Phase 1, Randomised, Double-Blind, Placebo-Controlled, Dose-Escalation First-Time-in-Human Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of Single and Repeat Oral Doses of FDL169 in Healthy Volunteers

• IRAS ID

  165122

• Contact name

  K M Donaldson

• Sponsor organisation

  Flatley Discovery Labs

• Eudract number

  2014-000866-23

• Duration of Study in the UK

  0 years, 8 months, 23 days

• Research summary

  This first in human study is looking at a drug called FDL169 which is a drug designed for the treatment of Cystic Fibrosis (CF). The purpose of this study is to look at the safety, tolerability and pharmacokinetics (of single and multiple ascending doses of FDL169 in healthy subjects.

  The population eligible to take part in the study includes healthy male subjects age 18 to 45 years, in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, spirometry and laboratory tests completed during screening at Simbec.

  The study will be conducted in two parts. Part 1 is single ascending dose (SAD) design, with an addition Fed/Fasted arm. Part 2 is a multiple ascending dose (MAD) design.

  Approximately 120 healthy male participants (“subjects”) are planned to be enrolled in this study, which will be conducted in 2 parts. Approximately 72 subjects are planned to be enrolled in Part 1a and 1b and up to 48 subjects are planned to be enrolled in Part 2 (additional subjects may be enrolled in one or both parts if needed. A maximum of an additional 32 subjects for Part 1. A maximum of an additional 24 subjects in Part 2).

• REC name

  Wales REC 2

• REC reference

  14/WA/1201

• Date of REC Opinion

  25 Nov 2014

• REC opinion

  Further Information Favourable Opinion