NCT02076919

First-in-Human Study of LHA510 in Elderly Subjects and Patients With Age-Related Macular Degeneration

A Randomized, Double-Masked, Vehicle-Controlled, First-in-Human Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of Topically Delivered LHA510 in Elderly Subjects and Patients With Age-Related Macular Degeneration

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 55 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The purpose of this first-in-human study is to assess the local ocular and systemic safety and tolerability of LHA510 eye drops when administered at various concentrations and dosing frequencies.

Detailed description

This first-in-human study was conducted in two parts. Part 1 was a single ascending dose (SAD) design to assess the local ocular and systemic safety and tolerability of a single topical eye drop of LHA510 administered at various concentrations. Four separate cohorts of unique elderly subjects (55 to 80 years) were utilized, with each cohort randomized to receive either topical LHA510 or vehicle in a 3:1 ratio as a single dose. A disposition evaluation was performed 7 days later. Part 2 was a multiple ascending dose (MAD) design to assess the local ocular and systemic safety and tolerability of LHA510 administered at various concentrations and dosing frequencies. Six separate cohorts of unique AMD subjects were utilized, with each cohort randomized to receive either topical LHA510 or vehicle in a 3:1 ratio for 7 days. A disposition evaluation was performed 14 days after the first dose of study drug. A review of all available safety data was conducted by the Sponsor and the PI(s) prior to dose escalation (cohort progression). The same concentrations levels were used in Part 1 and Part 2 and are ordered as Lowest, Next Lowest, Next Highest, and Highest.

Conditions

• Age-Related Macular Degeneration

Interventions

Type	Name	Description
DRUG	LHA510 Ophthalmic Suspension	Ophthalmic suspension in 4 concentration levels topically administered in Part 1 and Part 2
DRUG	LHA510 Vehicle	Inactive ingredients used for masking purposes

Timeline

• Start date: 2014-02-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2014-03-04
• Last updated: 2016-04-01
• Results posted: 2015-09-04