SAD/MAD, Safety, Tolerability and PK study of rh-NGF Eye Drops

• Research type

  Research Study

• Full title

  A phase I, Randomised, Double-masked, Placebo-Controlled, Combined Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Recombinant Human Nerve Growth Factor Eye Drops in Healthy Male and Female Volunteers

• IRAS ID

  115988

• Contact name

  Thierry Kamtchoua

• Sponsor organisation

  Dompé, s.p.a.

• Eudract number

  2012-004302-10

• ISRCTN Number

  N/A

• Research summary

  Dompe is currently developing rh-NGF (recombinant human Nerve Growth Factor) as a treatment for Neurotrophic Keratitis and dry eye disease. The purpose of this study is to assess the safety and tolerability, systemic pharmacokinetics and immunogenicity of single and multiple ascending doses of rh-NGF when administered as eye drops in healthy subjects. This is a randomised, double-masked, placebo-controlled eye drop administration study in healthy male and female subjects consisting of an ascending single dose or sentinel part (Part 0, one drop only), an ascending dose part (part A; three drops only, one drop every 4 h) and a multiple ascending dose part (part B, three drops a day, one drop every 4 h, for five days ). Each part will consist of 3 ascending dose levels. In part 0 each cohort will include 3 subjects treated with rh-NGF. In part A, each cohort will include 6 subjects treated with rh-NGF and 2 with placebo. In part B, each cohort will include 9 subjects treated with rh-NGF and 3 with placebo, in addition to cohort 0M, which will include 3 subjects treated with rh-NGF and 1 with placebo. The study is expected to include approximately 73 healthy subjects, 9 in Part 0, the sentinel group, 24 in Part A and 40 in Part B. Subjects will be confined to the Research Unit from the day before the dosing day (Day -1) in part 0 and two days (Day -2) before the dosing day in parts A and B until two days after the dosing day (Day 3) in parts 0 and A and two days after the last administration of study drug (Day 7) in part B.

• REC name

  North East - York Research Ethics Committee

• REC reference

  12/NE/0349

• Date of REC Opinion

  18 Oct 2012

• REC opinion

  Favourable Opinion