MedTrace Logo

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

NCT03836859 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-12-26

Study results available
· View outcomes & findings →

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.

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.

Sponsors & Collaborators

  • Cromsource

    collaborator INDUSTRY

  • Dompé Farmaceutici S.p.A

    lead INDUSTRY

Principal Investigators

  • Flavio Mantelli, MD, PhD · Dompé SpA Milan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-30
Primary Completion
2018-06-01
Completion
2018-06-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03836859 on ClinicalTrials.gov