4B Technologies (Beijing) Co., Limited

主要目的： 评价FB1002在中国成年健康参与者中单次皮下注射给药的安全性和耐受性。 次要目的： 评价FB1002在中国成年健康参与者中单次皮下注射给药后的药代动力学特征和免疫原性。 探索性目的： 探索FB1002在中国成年健康参与者中单次皮下注射给药后药效动力学特征及其它生物标志物的变化。

This study is designed for single-center, open-label, dose escalation phase I trial to evaluate the safety and tolerability of a single/multiple intravitreal injection of FB1001 in patients with APACG(Acute Primary Angle-Closure Glaucoma) or NAION(Nonarteritic Anterior Ischemic Optic Neuropathy).

The purpose of Part 1 is to evaluate safety and tolerability of FB1003 when given subcutaneously to healthy participants. Blood tests will be done to examine blood exposure, concentration and half-life of FB1003 following administrations. For each participant, the study will last up to about 12 weeks for single ascending dose part, and 18 weeks for multiple ascending dose part, including screening.
The purpose of Part 2 is to assess the safety, tolerability, PK and efficacy of SAD of SC administered FB1003 in adult subjects with osteoarthritis (OA) pain.