Study to Evaluate Safety, Tolerability and Pharmacokinetics of rhNGF Eye Drops in Healthy Volunteers

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.

Conditions

• Healthy

Interventions

DRUG

rhNGF 0.5 µg/mL Sentinel

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

DRUG

rhNGF 5 µg/mL Sentinel

Part 0 represented a sentinel group.

DRUG

rhNGF 20 µg/mL Sentinel

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

DRUG

rhNGF 20 µg/mL Part A

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.

DRUG

rhNGF 60 µg/mL Part A

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.

DRUG

rhNGF 180 µg/mL Part A

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.

DRUG

rhNGF 20 µg/mL Part B

In Part B, as planned 3 dose levels of rh-NGF or placebo eye drops were studied in a total of 40 healthy subjects.

DRUG

rhNGF 60 µg/mL Part B

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.

DRUG

rhNGF 180 µg/mL Part B

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.

DRUG

Placebo Part A

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.

DRUG

Placebo Part B

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.

Sponsors & Collaborators

• Covance

  collaborator INDUSTRY

• Dompé Farmaceutici S.p.A

  lead INDUSTRY

Principal Investigators

• Thierry Kamtchoua, MD · Covance Basel Research Unit AG

• Ashley Brooks, MBChB · Covance

• Pier Adelchi Ruffini, MD · Dompé s.p.a.Via San Martino, 12 - 20122 Milan, Italy

• Mauro P Ferrari, PharmD · Dompé s.p.a. - Via San Martino, 12 - 20122 Milan, Italy

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2012-07-31

Primary Completion

2013-02-28

Completion

2013-03-31

Countries

• Switzerland
• United Kingdom

Study Locations