靶点- |
作用机制- |
|
|
在研适应症- |
非在研适应症- |
最高研发阶段临床1期 |
首次获批国家/地区- |
首次获批日期- |
|
|
在研机构- |
|
在研适应症- |
|
最高研发阶段终止 |
首次获批国家/地区- |
首次获批日期- |
靶点- |
作用机制- |
在研机构- |
|
在研适应症- |
|
最高研发阶段无进展 |
首次获批国家/地区- |
首次获批日期- |
A Double-blind, Placebo-controlled, Study of the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of Oral AFA-281 (Phase I Part 1) and Multiple Ascending Doses of Oral AFA-281 (Phase I Part 2) in Healthy Volunteers
Phase I Part 1 (single ascending dose):
Double-blind dosing will occur in healthy volunteers in 5 cohorts of 8 subjects each. Six subjects in each cohort will be randomized to receive AFA-281 and 2 subjects will be randomized to receive the matching placebo. At the end of the Part 1 study is to evaluate the safety and tolerability of AFA-281. Following completion of each cohort, bioanalytical analyses will be conducted to evaluate the pharmacokinetic profile.
Phase I Part 2 (multiple dose for 14 days):
Pending the results from Part 1, healthy volunteers will be administered AFA-281 for 14 consecutive days in 3 cohorts. At scheduled intervals after dosing, and at the end of the cohort's study period to evaluate the safety and tolerability of AFA-281 and the pharmacokinetic profile of AFA-281.
100 项与 AfaSci, Inc. 相关的临床结果
0 项与 AfaSci, Inc. 相关的专利(医药)
100 项与 AfaSci, Inc. 相关的药物交易
100 项与 AfaSci, Inc. 相关的转化医学