Study to Evaluate Safety, Tolerability & PK of rhNGF in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to assess the safety and tolerability of a single
      short-term and a multiple dose scheme of rhNGF when administered as eye drops in healthy
      subjects of Japanese ethnicity.

      The secondary objective of this study is to assess the pharmacokinetics of single and
      multiple doses of rhNGF when administered as eye drops in healthy subjects of Japanese
      ethnicity.
    

Detailed description: 
      This is a Phase I, randomized, double-masked, placebo-controlled eye drops administration
      study of rhNGF in healthy male and female subjects of Japanese Ethnicity to evaluate the
      Safety, Tolerability and Pharmacokinetics of Recombinant Human Nerve Growth Factor Eye Drops
      (rhNGF 20 μg/mL -formulation containing L-methionine as excipient) versus vehicle (vehicle
      control containing L-methionine as excipient) in Healthy Male and Female Volunteers of
      Japanese Ethnicity. The IMP was administered in the study Eye with the following scheme:

      Day 1: One drop instilled into study eye (35 μL, corresponding to 0.70 μg of rhNGF).

      Day 2, 3, 4, 5, 6: One drop six times a day (every 2h) into study eye (210 μL, corresponding
      to 4.20 μg of rhNGF).

      Total dose in the study eye will be 31 drops (1085 μL, equivalent to 21.7 μg rhNGF) over 6
      days.

      The reference product (vehicle) was administered in the study eye with the following scheme:

      Day 1: One drop instilled into study eye (35 μL, corresponding to 0 μg of rhNGF].

      Day 2, 3, 4, 5, 6: One drop six times a day (every 2h) into study eye (210 μL, corresponding
      to 0 μg of rhNGF).

      A total dose of placebo vehicle in the study eye will be 31 drops (1085 μL, 0 μg rhNGF) over
      6 days.

      For the Fellow (Non-Study) Eye for all subjects, the scheme was the following:

      Day 1: One drop instilled into a fellow eye (35 μL, corresponding to 0 μg of rhNGF).

      Day 2, 3, 4, 5, 6: One drop six times a day (every 2h) into a fellow eye (210 μL,
      corresponding to 0 μg of rhNGF).

      A total dose of placebo vehicle in the fellow eye will be 31 drops (1085 μL, 0 μg rhNGF) over
      6 days.
    

Intervention name(s): rhNGF 20μg/mL; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Study Eye (For subjects randomized to rhNGF group) Day 1: One drop instilled into study eye (35 μL, corresponding to 0.70 μg of rhNGF).
Day 2, 3, 4, 5, 6: One drop six times a day (every 2h) into study eye (210 μL, corresponding to 4.20 μg of rhNGF).
Total dose in the study eye will be 31 drops (1085 μL, equivalent to 21.7 μg rhNGF) over 6 days.; Vehicle: formulation containing L-methionine as excipient.
Other intervention name(s): cenegermin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tolerability and PK