Pre-Phase I Evaluations
第一阶段前期评估
基本信息
- 批准号:8404840
- 负责人:
- 金额:$ 57.56万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2012
- 资助国家:美国
- 起止时间:2012-06-22 至 2017-05-31
- 项目状态:已结题
- 来源:
- 关键词:Anti-Retroviral AgentsAntiviral AgentsBiological AssayBiological MarkersBloodCervicalCharacteristicsClinicalClinical ResearchColonDataData SetDecision MakingDevelopmentDistalDoseDrug FormulationsDrug KineticsEvaluationFailureFundingFutureGelGoalsGrantHIVHIV InfectionsHIV-1Home environmentHourImageIn VitroInstructionLaboratoriesLicensingLiquid substanceLubricantsMeasurementMeasuresMetabolic Clearance RateMethodsModificationOutcomeParticipantPathway interactionsPenetrationPerceptionPerformancePermeabilityPharmaceutical PreparationsPharmacodynamicsPhasePlacebosPreventionProgram Research Project GrantsQuestionnairesRadiolabeledResearchResearch DesignSafetySamplingSensorySeriesSigmoid colonTenofovirTissue SampleTissuesToxic effectToxicologyVaginaValidationWorkabsorptionanalytical methodcomparativeexperiencehealthy volunteerimprovedmicrobicidenovelphase 1 studyprimary outcomeprogramsradiotracerrectalrectal microbicideresearch clinical testingsexspatiotemporalsuccessvaginal microbicide
项目摘要
PROJECT SUMMARY (See instructions):
This Proposal is part of a Program project grant focusing on combination antiretroviral microbicides formulated in a gels optimized or vaginal use and for rectal use for the prevention of sexually-tranmitted HIV infection. This project includes a series of pre-Phase I studies that will assess the pharmacokinetic, pharmacodynamic (anti-HIV efficacy and toxicity), and acceptability characteristics of a combination microbicide simultaneously.
Specific Aim 1. Methods Validation. Develop and validate assays for 0528 in blood, tissue, and luminal fluid, improve tenofovir intracellular assay sensitivity, verify compatibility of radiolabels with gel formulations, and cross-validate HIV explant methods with existing IP/CP funded labs for comparability.
Specific Aim 2. Impact of Rectal Gel Volume on Distribution Comparative pre-Phase I Study. Compare colonic distribution and permeability with 3.5 mL v. 10 mL rectal placebo gel to inform final dose formulation for pre-Phase I clinical studies in Aim 3 & Aim 4.
Specific Aim 3. Exploratory 0528 gel pre-Phase I PK/PD/Acceptability Study. Compare the spatiotemporal distribution (cervicovaginal, rectal, systemic), explant tissue anti-HIV effect, toxicological assessment, and acceptability of the 0528 candidate gel formulation for vaginal and rectal dosing in an exploratory pre-Phase I clinical study.
Specific Aim 4. Exploratory combination 0528/tenofovir pre-Phase I PK/PD/Acceptability Study. Compare the spatiotemporal distribution (cervicovaginal, rectal, systemic), explant tissue anti-HIV effect, toxicological assessment, and acceptability of the 0528/tenofovir candidate gel formulation for vaginal and rectal dosing in an exploratory pre-Phase I clinical study.
项目摘要(参见说明):
该提案是一项计划项目赠款的一部分,重点是配制在凝胶中的组合抗逆转录病毒杀菌剂,优化或阴道使用和直肠使用,以预防性传播艾滋病毒感染。该项目包括一系列第一阶段前研究,将同时评估组合杀菌剂的药代动力学、药效学(抗艾滋病毒功效和毒性)和可接受性特征。
具体目标 1. 方法验证。开发和验证血液、组织和管腔液中 0528 的检测方法,提高替诺福韦细胞内检测灵敏度,验证放射性标记与凝胶制剂的兼容性,并与现有 IP/CP 资助的实验室交叉验证 HIV 外植体方法以实现可比性。
具体目标 2. 直肠凝胶体积对分布比较 I 期前研究的影响。将结肠分布和渗透性与 3.5 mL 与 10 mL 直肠安慰剂凝胶进行比较,以了解目标 3 和目标 4 中 I 期前临床研究的最终剂量配方。
具体目标 3. 探索性 0528 凝胶 I 期前 PK/PD/可接受性研究。在一项探索性 I 期临床前研究中,比较 0528 候选凝胶制剂用于阴道和直肠给药的时空分布(宫颈阴道、直肠、全身)、外植体组织抗 HIV 效果、毒理学评估和可接受性。
具体目标 4. 探索性组合 0528/替诺福韦 I 期 PK/PD/可接受性研究。在一项探索性 I 期临床前研究中,比较 0528/替诺福韦候选凝胶制剂用于阴道和直肠给药的时空分布(宫颈阴道、直肠、全身)、外植体组织抗 HIV 效果、毒理学评估和可接受性。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
数据更新时间:{{ journalArticles.updateTime }}
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
数据更新时间:{{ journalArticles.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ monograph.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ sciAawards.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ conferencePapers.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ patent.updateTime }}
Craig Walter Hendrix其他文献
Craig Walter Hendrix的其他文献
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
{{ truncateString('Craig Walter Hendrix', 18)}}的其他基金
Population Pharmacokinetic Modeling and Clinical Trial Simulation to optimize HIV Prevention in Pregnancy and Postpartum
群体药代动力学模型和临床试验模拟可优化妊娠期和产后的艾滋病毒预防
- 批准号:
10316144 - 财政年份:2021
- 资助金额:
$ 57.56万 - 项目类别:
Development of Rectal Enema As Microbicide (DREAM)
直肠灌肠剂作为杀菌剂的开发(DREAM)
- 批准号:
9088326 - 财政年份:2014
- 资助金额:
$ 57.56万 - 项目类别:
Exploratory Pharmcokinetics of UC781 & Tenofovir Vaginal Microbicide Gel V Film
UC781 的探索性药代动力学
- 批准号:
8660270 - 财政年份:2014
- 资助金额:
$ 57.56万 - 项目类别:
Clinical optimization of a tenofovir enema and adherence tracking
替诺福韦灌肠和依从性跟踪的临床优化
- 批准号:
8768695 - 财政年份:2014
- 资助金额:
$ 57.56万 - 项目类别:
Exploratory Pharmcokinetics of UC781 & Tenofovir Vaginal Microbicide Gel V Film
UC781 的探索性药代动力学
- 批准号:
8471644 - 财政年份:2013
- 资助金额:
$ 57.56万 - 项目类别:
The effect of Depo-Provera on HIV susceptibility, immune activation, and PrEP PK
Depo-Provera 对 HIV 易感性、免疫激活和 PrEP PK 的影响
- 批准号:
8588047 - 财政年份:2013
- 资助金额:
$ 57.56万 - 项目类别:
相似海外基金
Development of a new generation of antiviral agents that are effective against drug-resistant viruses and prevent serious illness and sequelae.
开发新一代抗病毒药物,可有效对抗耐药病毒并预防严重疾病和后遗症。
- 批准号:
23K18186 - 财政年份:2023
- 资助金额:
$ 57.56万 - 项目类别:
Grant-in-Aid for Challenging Research (Exploratory)
A versatile structure-based therapeutic platform for development of VHH-based antitoxin and antiviral agents
一个多功能的基于结构的治疗平台,用于开发基于 VHH 的抗毒素和抗病毒药物
- 批准号:
10560883 - 财政年份:2023
- 资助金额:
$ 57.56万 - 项目类别:
Genetically encoded bicyclic peptide libraries for the discoveryof novel antiviral agents
用于发现新型抗病毒药物的基因编码双环肽库
- 批准号:
10730692 - 财政年份:2021
- 资助金额:
$ 57.56万 - 项目类别:
Design and synthesis of nucleosides to develop antiviral agents and oligonucleotide therapeutics
设计和合成核苷以开发抗病毒药物和寡核苷酸疗法
- 批准号:
21K06459 - 财政年份:2021
- 资助金额:
$ 57.56万 - 项目类别:
Grant-in-Aid for Scientific Research (C)
Genetically encoded bicyclic peptide libraries for the discoveryof novel antiviral agents
用于发现新型抗病毒药物的基因编码双环肽库
- 批准号:
10189880 - 财政年份:2021
- 资助金额:
$ 57.56万 - 项目类别:
Computer-aided identification and synthesis of novel broad-spectrum antiviral agents
新型广谱抗病毒药物的计算机辅助鉴定和合成
- 批准号:
2404261 - 财政年份:2020
- 资助金额:
$ 57.56万 - 项目类别:
Studentship
Develop broad-spectrum antiviral agents against COVID-19 based on innate immune response to SARS-CoV-2 infection
基于对 SARS-CoV-2 感染的先天免疫反应,开发针对 COVID-19 的广谱抗病毒药物
- 批准号:
10222540 - 财政年份:2020
- 资助金额:
$ 57.56万 - 项目类别:
Develop broad-spectrum antiviral agents against COVID-19 based on innate immune response to SARS-CoV-2 infection
基于对 SARS-CoV-2 感染的先天免疫反应,开发针对 COVID-19 的广谱抗病毒药物
- 批准号:
10669717 - 财政年份:2020
- 资助金额:
$ 57.56万 - 项目类别:
Association between sedentary lifestyle and liver cancer development in hepatitis C patients treated with direct-acting antiviral agents
接受直接抗病毒药物治疗的丙型肝炎患者久坐的生活方式与肝癌发展之间的关系
- 批准号:
20K10713 - 财政年份:2020
- 资助金额:
$ 57.56万 - 项目类别:
Grant-in-Aid for Scientific Research (C)
Develop broad-spectrum antiviral agents against COVID-19 based on innate immune response to SARS-CoV-2 infection
基于对 SARS-CoV-2 感染的先天免疫反应,开发针对 COVID-19 的广谱抗病毒药物
- 批准号:
10174522 - 财政年份:2020
- 资助金额:
$ 57.56万 - 项目类别:














{{item.name}}会员




