A Randomized, Double-blind, Placebo-controlled, First-in-human, 3-Part Study of Orally Administered ALS-002158 to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Dosing and Food-effect in Healthy Volunteers, and Multiple Ascending Dosing in Subjects With Chronic Hepatitis C Genotype 1 Infection

This randomized, double-blind, placebo-controlled, 3-part study will assess the safety, tolerability, and pharmacokinetics of orally administered ALS-002158 in healthy volunteers (HV) and subjects with chronic hepatitis C (CHC) genotype 1 infection.
Part 1 will assess single ascending dosing pharmacokinetics and safety in HV. Part 2 will assess food effects on pharmacokinetics in HV.
Part 3 will assess multiple ascending dosing pharmacokinetics and safety in subjects with CHC genotype 1 infection.

开始日期2011-12-31

申办/合作机构

Alios BioPharma, Inc.

[+1]

ACTRN12612000176864 / Recruiting临床1期

A Randomized, Double-blind, Placebo-controlled, First-in-human, 3-Part Study of Orally Administered ALS-002158 to Evaluate the Safety, Tolerability and Pharmacokinetics ofSingle Ascending Dosing and Food-effect in Healthy Volunteers, and Multiple Ascending Dosing in Subjects with Chronic Hepatitis C Genotype 1 Infection.

开始日期2011-12-15

申办/合作机构

CPR Pharma Services Pty Ltd.

100 项与 ALS-2158 相关的临床结果

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100 项与 ALS-2158 相关的转化医学

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100 项与 ALS-2158 相关的专利（医药）

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项与 ALS-2158 相关的文献（医药）

2014-06-01·Biochemical pharmacology2区 · 医学

Current race in the development of DAAs (direct-acting antivirals) against HCV

2区 · 医学

Article

作者: De Clercq, Erik

The direct-acting antivirals (DAAs) currently in development for treatment of hepatitis C fall into four categories: (i) NS3/4A protease inhibitors: ABT-450/r, faldaprevir, asunaprevir, GS-9256, vedroprevir (GS-9451), danoprevir, MK-5172, vaniprevir, sovaprevir, ACH-2684, narlaprevir and simeprevir, in addition to those that are already developed [telaprevir (Incivek®) and boceprevir (Victrelis®)], (ii) NS5A protein inhibitors: ABT-267, daclatasvir, ledipasvir, ACH-2928, ACH-3102, PPI-668, AZD-7295, MK-8742, and GSK 2336805; (iii) NS5B (nucleoside-type) polymerase inhibitors: sofosbuvir (now approved by the FDA since 6 December 2013), GS-0938, mericitabine, VX-135, ALS 2158 and TMC 649128; (iv) NS5B (non-nucleoside-type) polymerase inhibitors: VX-222, ABT-072, ABT-333, deleobuvir, tegobuvir, setrobuvir, VCH-916, VCH-759, BMS-791325 and TMC-647055. Future drug combinations will likely exist of two or more DAAs belonging to any of the 4 categories, with the aim to achieve (i) pan-genotypic hepatitis C virus (HCV) activity, (ii) little or no risk for resistance; (iii) short duration (i.e. 12 weeks) of treatment, and (iv) a sustained viral response (SVR) and definite cure of the disease.

100 项与 ALS-2158 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
慢性丙型肝炎基因型 1	临床1期	澳大利亚	Vertex Pharmaceuticals, Inc.	2011-12-31
慢性丙型肝炎基因型 1	临床1期	澳大利亚	Alios BioPharma, Inc.	2011-12-31
慢性丙型肝炎基因型 1	临床1期	新西兰	Alios BioPharma, Inc.	2011-12-31
慢性丙型肝炎基因型 1	临床1期	新西兰	Vertex Pharmaceuticals, Inc.	2011-12-31