NCT01744704 - Study to Evaluate Safety, Tolerability and Pharmacokinetics of rhNGF Eye Drops in Healthy Volunteers | Biotech Hunter

Enrollment

74

Participants

Timeline

Start Date

July 31, 2012

Primary Completion Date

February 28, 2013

Study Completion Date

March 31, 2013

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.

Trial Locations (2)

CH - 4123

Covance Basel Research Unit AG - Lettenweg 118 -, Allschwil

LS2 9LH

COVANCE CLINICAL RESEARCH UNIT Ltd - Springfield House - Hyde Street, Leeds