Study to Evaluate Safety, Tolerability and Pharmacokinetics of rhNGF Eye Drops in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to assess the safety and tolerability of single and
      multiple ascending doses of rhNGF when administered as eye drops in healthy subjects.
    

Detailed description: 
      This is a Phase I, randomised, double-masked, placebo-controlled eye drops administration
      study of rh-NGF in healthy male and female subjects.

      This study consists of a single ascending dose part (part 0 one drop single application).
      Then single ascending dose part (part A; one drop three times a day) and a multiple ascending
      dose part (part B; one drop three times a day for five days). All parts of the study will
      consist of 3 ascending dose levels.

      In order to support the dose escalation MAD phase from Covance, Basel to Covance, Leeds, an
      additional cohort (0M) will be conducted at Covance, Leeds at the same dose level as cohort
      1M to ensure a degree of consistency between the two sites, i.e. that no dose escalation
      stopping criteria were met at either site.

      In Part 0, each ascending dose cohort will include 3 subjects treated with one dose of
      rh-NGF.

      In part A, each ascending dose cohort will include 6 subjects treated with rh-NGF and 2 with
      placebo.

      In part B, each ascending dose cohort will include 9 subjects treated with rh-NGF drug and 3
      with placebo, in addition to cohort 0M, which will include 3 subjects treated with rh-NGF and
      1 with placebo
    

Intervention name(s): rhNGF 0.5 µg/mL Sentinel; rhNGF 5 µg/mL Sentinel; rhNGF 20 µg/mL Sentinel; rhNGF 20 µg/mL Part A; rhNGF 60 µg/mL Part A; rhNGF 180 µg/mL Part A; rhNGF 20 µg/mL Part B; rhNGF 60 µg/mL Part B; rhNGF 180 µg/mL Part B; Placebo Part A; Placebo Part B
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): In Part 0, all subjects received one 35-μL drop of rh-NGF at an appropriate concentration in the study eye (right or left) according to the randomisation list to achieve the required dose level; Part 0 represented a sentinel group.; In Part 0, all subjects received one 35-μL drop of rh-NGF at an appropriate concentration in the study eye (right or left) according to the randomisation list to achieve the required dose level; In Part A, all subjects received one 35-μL drop of rh-NGF at an appropriate concentration or placebo in their study eye (right or left) according to the randomisation list (and 1 drop of placebo in the non-study eye). This occurred q4h on Day 1 to achieve the required fractionated single dose level.; In Part A, all subjects received one 35-μL drop of rh-NGF at an appropriate concentration or placebo in their study eye (right or left) according to the randomisation list (and 1 drop of placebo in the non-study eye). This occurred q4h on Day 1 to achieve the required fractionated single dose level.; In Part A, all subjects received one 35-μL drop of rh-NGF at an appropriate concentration or placebo in their study eye (right or left) according to the randomisation list (and 1 drop of placebo in the non-study eye). This occurred q4h on Day 1 to achieve the required fractionated single dose level.; In Part B, as planned 3 dose levels of rh-NGF or placebo eye drops were studied in a total of 40 healthy subjects.; In Part B, all subjects received one 35-μL drop of rh-NGF at an appropriate concentration or placebo in their study eye (right or left) according to the randomisation list (and 1 drop of placebo in the non-study eye). This occurred q4h for 5 days to achieve the required multiple fractionated dose level.; In Part B, all subjects received one 35-μL drop of rh-NGF at an appropriate concentration or placebo in their study eye (right or left) according to the randomisation list (and 1 drop of placebo in the non-study eye). This occurred q4h for 5 days to achieve the required multiple fractionated dose level.; In Part A, all subjects received one 35-μL drop of rh-NGF at an appropriate concentration or placebo in their study eye (right or left) according to the randomisation list (and 1 drop of placebo in the non-study eye). This occurred q4h on Day 1 to achieve the required fractionated single dose level.; In Part B, all subjects received one 35-μL drop of rh-NGF at an appropriate concentration or placebo in their study eye (right or left) according to the randomisation list (and 1 drop of placebo in the non-study eye). This occurred q4h for 5 days to achieve the required multiple fractionated dose level.
Other intervention name(s): Recombinant Human Nerve Growth Factor; Recombinant Human Nerve Growth Factor; Recombinant Human Nerve Growth Factor; Recombinant Human Nerve Growth Factor; Recombinant Human Nerve Growth Factor; Recombinant Human Nerve Growth Factor; Recombinant Human Nerve Growth Factor; Recombinant Human Nerve Growth Factor; Recombinant Human Nerve Growth Factor; Vehicle; Vehicle
Intervention MeSH terms: Mitogens
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Nerve Growth Factor; Ophthalmic Solutions; Eye Drops; rh-NGF