Conditions: Age-Related Macular Degeneration
Keywords: LHA510 First in human Safety Tolerability Pharmacokinetics Elderly Age-Related Macular Degeneration AMD Ocular Eye drop
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 110
Healthy volunteers: yes

Brief 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.

Arms:
arm 1: LHA510 Ophthalmic Suspension in 1 of 4 concentrations, 1 drop instilled in the study eye as a single dose during Part 1 arm 2: Inactive ingredients, 1 drop instilled in the study eye as a single dose during Part 1 arm 3: LHA510 Ophthalmic Suspension in 1 of 4 concentrations, 1 drop instilled in the study eye once, twice, or three times daily for 7 days during Part 2 arm 4: Inactive ingredients, 1 drop instilled in the study eye once, twice, or 3 times daily for 7 days during Part 2

Interventions: intervention 1: LHA510 Ophthalmic Suspension intervention 2: LHA510 Vehicle
Intervention descriptions: intervention 1: Ophthalmic suspension in 4 concentration levels topically administered in Part 1 and Part 2 intervention 2: Inactive ingredients used for masking purposes

Protocol document: