Study to Evaluate Safety, Tolerability & PK of rhNGF in Healthy Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

March 30, 2018

Primary Completion Date

June 1, 2018

Study Completion Date

June 1, 2018

Conditions
Healthy Volunteers
Interventions
DRUG

rhNGF 20μg/mL

"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."

OTHER

Placebo

Vehicle: formulation containing L-methionine as excipient.

Trial Locations (1)

90630

WCCT Global, Cypress

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Cromsource

INDUSTRY

lead

Dompé Farmaceutici S.p.A

INDUSTRY

NCT03836859 - Study to Evaluate Safety, Tolerability & PK of rhNGF in Healthy Volunteers | Biotech Hunter | Biotech Hunter