AEF-0217(AEF-0217) - 药物靶点：CB1R_在研适应症：唐氏综合征_专利_临床

概要

基本信息

药物类型

小分子化药

别名

靶点

CB1R

作用机制

CB1拮抗剂(大麻素受体CB1拮抗剂)

治疗领域

神经系统疾病遗传病与畸形其他疾病

在研适应症

唐氏综合征

非在研适应症-

原研机构

Aelis Farma SA

在研机构

Aelis Farma SA

非在研机构-

最高研发阶段临床1/2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

2

项与 AEF-0217 相关的临床试验

NCT05748405 / Completed临床1/2期

A Double-blind, Randomized, Placebo-controlled, 4-week, Phase 1/2 Trial in Young Adult Participants With Down Syndrome to Assess the Safety, Tolerability, Plasma Exposure, and Preliminary Indications of Pharmacodynamic Activity of AEF0217

AEF0217-102 clinical trial assesses the safety, tolerability, plasma exposure and preliminary indications of pharmacodynamic activity of AEF0217 in female and male adult participants with Down syndrome between 18 and 35 years old.
The trial AEF0217-102 is a double-blind, randomized, placebo-controlled, multiple-dose, 4-week phase 1/2 study. After a screening period, the participant will be randomised and will take an oral dose of AEF0217 0.2mg or placebo once a day for 28 days.

开始日期2022-12-15

申办/合作机构

Aelis Farma SA

NCT05170737 / Completed临床1期

A First-In-Human Phase I Study in 3 Parts: Randomized, Double-blind, Placebocontrolled, Sequential Group Investigation of the Safety, Tolerability, Pharmacokinetics of AEF0217 After Oral, Single and Multiple Ascending Doses, and an Open Label, Cross-over Investigation of the Effect of Food on the Bioavailability of AEF0217 in Healthy Volunteers.

This trial is divided in 3 parts: FIH-SAD (Single Ascending Doses), FIH-MAD (Multiple Ascending Doses) and FIH-FE (Food effects). FIH-SAD will start first. The start of FIH-MAD will await the results of at least three cohorts from the FIHSAD study before initiated. The starting dose of the FIH-MAD will have been shown to be well tolerated and one dose level lower than the highest dose for which safety, tolerability and pharmacokinetic (PK) data are available. FIH-FE will be the last to start after the completion of FIH-SAD and conducted in parallel with parts of FIH-MAD.

开始日期2021-10-01

申办/合作机构

Aelis Farma SA

100 项与 AEF-0217 相关的临床结果

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100 项与 AEF-0217 相关的转化医学

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100 项与 AEF-0217 相关的专利（医药）

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100 项与 AEF-0217 相关的药物交易

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