NCT04403763

Phase 1/2 Study of AGN-241622 in Healthy Participants and Participants With Presbyopia

A First-in-Human, Phase 1/2, Dose-ascending, Multicenter, Masked, Randomized, Vehicle-controlled Study Evaluating the Safety, Tolerability, and Pharmacokinetics of AGN-241622 in Healthy Participants and Participants With Presbyopia (Stage 1 and Stage 2) and Efficacy in Participants With Presbyopia (Stage 2)

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of AGN-241622 ophthalmic solution for the first time in human participants

Conditions

• Presbyopia

Interventions

Type	Name	Description
DRUG	AGN-241622	Topical eye drop
DRUG	Vehicle	Topical eye drop

Timeline

• Start date: 2020-07-27
• Primary completion: 2022-12-05
• Completion: 2022-12-05
• First posted: 2020-05-27
• Last updated: 2024-02-06
• Results posted: 2024-02-06

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study