A Double-blind, Placebo-controlled, Multi-center Phase II Study of the Safety, Tolerability, Pharmacokinetics, and Efficacy of Oral AFA-281 in Patients With Painful Lumbosacral Radiculopathy

The goal of this clinical trial is to evaluate if the drug candidate AFA-281 works to treat chronic low back and leg pain caused by painful lumbosacral radiculopathy (PLSR) in adults. This trial will also evaluate the safety of AFA-281. The main questions it aims to answer are:
* Does AFA-281 mitigate pain?
* What are the side effects (if any)? Researchers will compare AFA-281 to a placebo (a look-alike substance that contains no drug) to see if AFA-281 works to treat chronic low back and leg pain.
Participants will:
* Take drug AFA-281 or a placebo three times every day for 4 weeks
* Visit the clinic once every 2 weeks for checkups and tests
* Keep a diary of their pain scores and about mood and sleep questionnaires, and the number of times they use a rescue pain medicines.

开始日期2026-08-01

申办/合作机构

AfaSci, Inc.

NCT06710431

/ Not yet recruiting临床2期

A Double-blind, Placebo-controlled, Phase IIA Human Laboratory Study of the Safety and Exploratory Efficacy of Oral AFA-281 in Patients with Alcohol Use Disorder

This study will evaluate the safety and exploratory efficacy of AFA-281 in patients with Alcohol use disorder on cravings, subjective response to alcohol, pain thresholds, anxiety, depression, and sleep.

开始日期2025-10-01

申办/合作机构

AfaSci, Inc.

NCT06719908

/ Not yet recruiting临床1期

A Double-blind, Placebo-controlled, Phase I Study of the Pharmacokinetic and Pharmacodynamic Interaction of Oral AFA-281 With Alcohol in Healthy Volunteers

The goal of this clinical trial is to evaluate if alcohol interacts with the drug candidate AFA-281 in adults (healthy volunteers). This trial will evaluate blood concentration levels of AFA-281 and ethanol. The main questions it aims to answer are: Does alcohol interact with AFA-281? What are the side effects (if any)? Researchers will compare AFA-281 to a placebo (a look-alike substance that contains no drug) to see if AFA-281 interacts with alcohol.
Participants will take a total of 4 treatment sessions separated by at least 2 days between treatments. The treatments will incorporate AFA-281 or placebo with ethanol or ethanol placebo. After each treatment vital signs will be monitored and blood collected to measure AFA-281 and ethanol levels. Participants will provide an assessment survey of symptoms. The total treatment time will be 9 inpatient days (8 nights), and a final follow-up visit 3 to 5 days after clinic discharge.

开始日期2025-07-01

申办/合作机构

AfaSci, Inc.

100 项与 AFA-281 相关的临床结果

登录后查看更多信息

100 项与 AFA-281 相关的转化医学

登录后查看更多信息

100 项与 AFA-281 相关的专利（医药）

登录后查看更多信息

100 项与 AFA-281 相关的药物交易

登录后查看更多信息

研发状态

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
背痛	临床2期	-	AfaSci, Inc.	2026-08-01
腰骶神经根病变	临床2期	-	AfaSci, Inc.	2026-08-01
酗酒	临床2期	美国	AfaSci, Inc.	2025-10-01
焦虑症	临床2期	美国	AfaSci, Inc.	2025-10-01
睡眠异常	临床2期	美国	AfaSci, Inc.	2025-10-01
内源性抑郁症	临床2期	美国	AfaSci, Inc.	2025-10-01
疼痛	临床2期	美国	AfaSci, Inc.	2025-10-01
酒精使用障碍	临床1期	-	AfaSci, Inc.	2025-07-01
炎症性疼痛	临床1期	美国	AfaSci, Inc.	2023-04-11
神经痛	临床1期	美国	AfaSci, Inc.	2023-04-11