Clinical trials

Completed

A Phase I, Randomised, Double-masked, Placebo-controlled, Combined Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Recombinant Human Nerve Growth Factor Eye Drops in Healthy Male and Female Volunteers

NGF0112

What is the purpose of this study?

The primary objective of the study was:

  • to assess the safety and tolerability of single and multiple ascending doses of recombinant human nerve growth factor (rhNGF) when administered as eye drops in healthy subjects.

The secondary objectives were:

  • to determine the systemic pharmacokinetic (PK) characteristics following administration of single and multiple ascending doses of rhNGF when administered as eye drops in healthy subjects,
  • to assess the immunogenicity of rhNGF when administered as eye drops in healthy subjects.

Trial overview

Condition

Healthy subjects

Study Identifiers

NCT01744704

Study type

Safety
Tolerability and Pharmacokinetics

Intervention

Drug: rhNGF 0.5 µg/mL Sentinel
Drug: rhNGF 5 µg/mL Sentinel
Drug: rhNGF 20 µg/mL Sentinel
Drug: rhNGF 20 µg/mL Part A
Drug: rhNGF 60 µg/mL Part A
Drug: rhNGF 180 µg/mL Part A
Drug: rhNGF 20 µg/mL Part B
Drug: rhNGF 20 µg/mL Part B cohort 0M
Drug: rhNGF 60 µg/mL Part B
Drug: rhNGF 180 µg/mL Part B
Drug: Placebo Part A
Drug: Placebo Part B

Phase

I

Start date

Jul 2012

End Date

Mar2013

Enrollment Goal

73 subjects

Going deep into the trial

Eligibility/Recruitment

Age

 
18
 
60

Gender

Accepts healthy volunteers

Key Criteria

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Inclusion

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Exclusion

Some information about patients involvement

Study participation was approximately:

  • Part 0: 4 weeks
  • Part A: 6 weeks
  • Part B: 8 weeks

Desired Outcomes

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Primary Outcomes

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Secondary Outcomes

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