Evaluation of OLX10212 in Patients With Neovascular Age-related Macular Degeneration

Summary

This is a Phase 1, multicenter, open-label, single- and multi-dose, dose-escalating study of OLX10212 in patients with neovascular age-related macular degeneration (AMD). This study is composed of 2 parts: Part A and Part B. Part A is a single ascending dose study, and Part B is a multiple ascending dose study. The primary objective is to evaluate the safety and tolerability of single and multiple intravitreal injection(s) of OLX10212 in patients with neovascular AMD. The exploratory objectives are to evaluate the preliminary efficacy of single and multiple intravitreal injection(s) of OLX10212 in patients with neovascular AMD, and to evaluate the pharmacokinetics (PK) of single and multiple intravitreal injection(s) of OLX10212 in patients with neovascular AMD.

Timeline

Start

2023-01-04

Primary completion

2024-11-25

Completion

2025-11-10

Outcome

Met primary endpoint

release “올릭스, 황반변성 치료제 ‘OLX301A’ 임상 1상 평가지표 충족” olixpharma.com ↗

release “OLX301A는 단회 및 반복 투여 시험의 모든 용량 수준에서 우수한 안전성과 내약성을 입증하며 1상 임상 목표를 달성했다.” olixpharma.com ↗

Publications

• Background Hwang J, Chang C, Kim JH, Oh CT, Lee HN, Lee C, Oh D, Lee C, Kim B, Hong SW, Lee DK. Development of Cell-Penetrating Asymmetric Interfering RNA Targeting Connective Tissue Growth Factor. J Invest Dermatol. 2016 Nov;136(11):2305-2313. doi: 10.1016/j.jid.2016.06.626. Epub 2016 Jul 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	OLX10212	Small interfering RNA (siRNA)	100 ug	Intravitreal
Subject	OLX10212	Small interfering RNA (siRNA)	250 ug	Intravitreal
Subject	OLX10212	Small interfering RNA (siRNA)	500 ug	Intravitreal
Subject	OLX10212	Small interfering RNA (siRNA)	750 ug	Intravitreal
Subject	OLX10212	Small interfering RNA (siRNA)	950 ug	Intravitreal

Indications