This study has two parts. Part A will assess the safety, tolerability and pharmacokinetics (PK) of AT-777 in healthy subjects. Part B will assess the safety, antiviral activity/efficacy and PK of AT-777 in combination with AT-527 after 8 weeks of treatment in HCV-infected subjects.

Start Date01 Oct 2021

Sponsor / Collaborator

Atea Pharmaceuticals, Inc.

CTR20202688 / CompletedPhase 1

TQ-A3326片与百立泽在健康成年受试者中的药代动力学比对试验

[Translation] Comparative study on the pharmacokinetic performance of TQ-A3326 tablets and Baili Ze in healthy adult subjects

本试验目的是参考生物等效性评价方法，研究正大天晴药业集团股份有限公司提供的TQ-A3326片与AstraZenecaPharmaceuticalsLP生产的百立泽TM在健康成年受试者中的生物利用度及药代动力学特点，用以支持TQ-A3326片的注册申报。

[Translation]

The purpose of this study is to refer to the bioequivalence evaluation method to study the bioavailability and pharmacokinetic characteristics of TQ-A3326 tablets provided by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. and Baili ZeTM produced by AstraZeneca Pharmaceuticals LP in healthy adult subjects, in order to support the registration application of TQ-A3326 tablets.

Start Date25 Jan 2021

Sponsor / Collaborator

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

[+1]

CTR20192091 / CompletedPhase 1

在健康受试者中评价ASC18片中RDV与SOF的药物相互作用、食物影响及药代动力学研究

[Translation] Evaluation of drug interactions, food effects, and pharmacokinetics of RDV and SOF in ASC18 tablets in healthy subjects

评价ASC18片（RDV/SOF复方片）中RDV与SOF的药物相互作用；评价食物对ASC18片药代动力学的影响；比较ASC18片与RDV片和SOF片（RDV+SOF）联用的药动学参数。

[Translation]

To evaluate the drug interaction between RDV and SOF in ASC18 tablets (RDV/SOF compound tablets); to evaluate the effect of food on the pharmacokinetics of ASC18 tablets; and to compare the pharmacokinetic parameters of ASC18 tablets in combination with RDV tablets and SOF tablets (RDV+SOF).

Start Date12 Apr 2020

Sponsor / Collaborator

Ascletis Pharmaceuticals Co.,Ltd.

100 Clinical Results associated with Hepatitis C virus NS 5 protein

100 Translational Medicine associated with Hepatitis C virus NS 5 protein

0 Patents (Medical) associated with Hepatitis C virus NS 5 protein

Literatures (Medical) associated with Hepatitis C virus NS 5 protein

01 Nov 2018·Journal of Pharmacology and Experimental TherapeuticsQ3 · MEDICINE

Molecular Neuroprotection Induced by Zinc-Dependent Expression of Hepatitis C–Derived Protein NS5A Targeting Kv2.1 Potassium Channels

Q3 · MEDICINE

Article

Author: Palladino, Michael J ; Justice, Jason A ; Yeh, Chung-Yang ; Hartnett-Scott, Karen A ; Aizenman, Elias ; Manjooran, Daniel T ; Schulien, Anthony J ; Mammen, Shalom ; Kosobucki, Gabrielle J

We present the design of an innovative molecular neuroprotective strategy and provide proof-of-concept for its implementation, relying on the injury-mediated activation of an ectopic gene construct. As oxidative injury leads to the intracellular liberation of zinc, we hypothesize that tapping onto the zinc-activated metal regulatory element (MRE) transcription factor 1 system to drive expression of the Kv2.1-targeted hepatitis C protein NS5A (hepatitis C nonstructural protein 5A) will provide neuroprotection by preventing cell death-enabling cellular potassium loss in rat cortical neurons in vitro. Indeed, using biochemical and morphologic assays, we demonstrate rapid expression of MRE-driven products in neurons. Further, we report that MRE-driven NS5A expression, induced by a slowly evolving excitotoxic stimulus, functionally blocks injurious, enhanced Kv2.1 potassium whole-cell currents and improves neuronal viability. We suggest this form of "on-demand" neuroprotection could provide the basis for a tenable therapeutic strategy to prevent neuronal cell death in neurodegeneration.

01 Jun 2008·Journal of Viral HepatitisQ2 · MEDICINE

Strategies for loading dendritic cells with hepatitis C NS5a antigen and inducing protective immunity

Q2 · MEDICINE

Article

Author: H. Yu ; L. A. Babiuk ; S. Van Drunen Littel‐van den Hurk

Summary. Dendritic cell (DC)‐based vaccination strategies are promising for the treatment of cancers and infectious diseases including hepatitis C virus (HCV). As the induction of T cell‐mediated immune responses by DC vaccination is highly dependent on efficient antigen loading of the DCs, the purpose of this study was to identify an optimal nonviral DC loading strategy for HCV NS5a. Furthermore, the efficacy of immunization with the NS5a‐loaded DCs in comparison to plasmid encoding NS5a and NS5a protein was evaluated. Transfection of DCs with mRNA was most efficient with close to 100% of DCs expressing NS5a, whereas approximately 10% of protein‐pulsed DCs and <1% of plasmid‐transfected DCs expressed NS5a, suggesting remarkably different loading efficiencies. Vaccination of mice with NS5a mRNA‐transfected DCs or NS5a protein‐pulsed DCs resulted in significantly stronger CD4+ and CD8+ T‐cell responses and protection from challenge with vaccinia virus expressing NS3/NS4/NS5, in comparison to vaccination with NS5a DNA‐transfected DCs, plasmid encoding NS5 or rNS5a protein formulated with alum. Furthermore, vaccination with NS5a mRNA‐transfected DCs was superior to vaccination with rNS5a‐pulsed DCs. These data have important clinical implications, with mRNA‐transfected DCs providing a safe and effective vaccination strategy against hepatitis C and possibly other pathogens.

Molekuliarnaia biologiia

[DNA immunization with a plasmid containing gene of hepatitis C virus protein 5A (NS5A) induces the effective cellular immune response].

Article

Author: Lesnova, E I ; Ataullakhanov, R I ; Smirnova, O A ; Grabovetskiĭ, V V ; Zaberezhnyĭ, A D ; Masalova, O V ; Ivanov, A V ; Kushch, A A ; Ulanova, T I ; Burkov, A N

In spite of extensive research, no effective vaccine against hepatitis C virus (HCV) has been developed so far. DNA immunization is a potent technique of vaccine design strongly promoting the cellular arm of immune response. The genes encoding nonstructural HCV proteins (NS2-NS5B) are promising candidates for vaccine development. NS5A is a protein involved in viral pathogenesis, in the induction of immune response, and probably in viral resistance to interferon treatment. The objective of this study was to construct a DNA vaccine encoding NS5A protein and evaluate its immunogenicity. A plasmid encoding a full-size NS5A protein was produced using the pcDNA3.1 (+) vector for eukaryotic expression system. The expression of the NS5A gene was confirmed by immunoperoxidase staining of the transfected eukaryotic cells with anti-NS5A monoclonal antibodies. Triple immunization of mice with the plasmid vaccine induced a pronounced cellular immune response against abroad spectrum of NSSA epitopes as assessed by T-cell proliferation andsecretion of antiviral cytokines IFN-gamma and IL-2. In in vitro T-cell stimulation experiments, NS5A-derived antigens were modeled by synthetic peptides, recombinant proteins of various genotypes, and phages carrying exposed NS5A peptides. A novel immunomodulator Immunomax showed high adjuvant activity in DNA immunization. The data obtained indicate that the suggested DNA construct has a strong potential in the development of the gene vaccines against hepatitis C.

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