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Clinical Trial Summary

The purpose of this Phase 1 study is comprised of multiple ascending-dose component (Part 1) and high concentration component (Part 2) to evaluate the safety, tolerability, pharmacokinetics, and efficacy of AM712 in patients with neovascular age- related macular degeneration (nAMD).


Clinical Trial Description

The Part 1 of study is a multicenter, open-label, sequentially, multiple ascending-dose study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of AM712 in subjects with nAMD. Subjects will be sequentially enrolled into different dose-level cohorts following the traditional "3+3" design until the maximally tolerated dose (MTD) or the maximally administered dose (MAD) has been reached. The Part 2 of study is a multicenter, open-label, sequential study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of AM712 in treatment-naïve patients with nAMD. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05345769
Study type Interventional
Source AffaMed Therapeutics Limited
Contact Fan Yang
Phone +1 (306) 580-5857
Email fan.yang@affamed.com
Status Recruiting
Phase Phase 1
Start date April 28, 2022
Completion date June 30, 2024

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