Development of novel contraceptive methods for men and women

开发针对男性和女性的新型避孕方法

• 批准号: 10908195
• 负责人: Diana Blithe
• 金额: $ 98.63万
• 依托单位: EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10908195
• 关键词: Address; Agreement; Biological Testing; Chemistry; Clinical; Clinical Investigator; Clinical Trials; Clinical Trials Network; Contraceptive Agents; Contraceptive methods; Contracts; Cooperative Research and Development Agreement; Couples; Development; Devices; Dose; Evaluation; Formulation; Gel; Goals; Good Manufacturing Process; Hormonal; Human; Injectable; Institution; International; Lead; Male Contraceptive Agents; Mediation; Methods; Mission; National Institute of Child Health and Human Development; Pharmaceutical Preparations; Phase; Preparation; Program Development; Qualifying; Research; Research Personnel; Safety; Schedule; Scientist; Site; Technology Transfer; Testing; Toxicology; Training; Translating; Vagina; Woman; chemical synthesis; clinical efficacy; clinical research site; clinical trial protocol; drug candidate; efficacy study; first-in-human; good laboratory practice; innovation; manufacture; meetings; men; method development; next generation; novel; novel therapeutics; preclinical evaluation; preclinical study; programs; research and development; research clinical testing

CDP uses R&D contracts to achieve the goal of new method development. The Program evaluates new drugs that are not commercially available and must be synthesized under current Good Manufacturing Practice (cGMP) that comply with all regulatory standards of Chemistry, Manufacturing and Controls. CDP maintains a contracted Chemical Synthesis Facility to produce novel drugs required for the program. Potential new drugs and devices require toxicology testing to demonstrate safety. IND-enabling preclinical studies must be performed under Good Laboratory Practice (GLP) meeting regulatory standards. Human trials require formulation and release of agents under cGMP, and stability studies covering the duration of the trial. CDP maintains a Biological Testing Facility to perform preclinical evaluation and batch preparation required for first-in-human studies and longer toxicology studies for later Phase clinical trials. Clinical evaluation of the novel products occurs in the Contraceptive Clinical Trials Network (CCTN) under the Program Management of the CDP. The CCTN evaluates safety and efficacy of new contraceptive drugs and devices for women and for men. Results from clinical trials on new entities form the basis for advancing candidate drugs and devices through development with the goal of FDA regulatory approval. The CCTN comprises top clinical investigators at qualified institutions, including both domestic and international sites, with expertise to conduct all phases of contraceptive evaluation, from first-in-human through Phase III. The clinical sites serve as the training ground for the next generation of investigators in the field. A new Cooperative Research and Development Agreement (CRADA) was negotiated and approved in 2021. The goal of the CRADA is to conduct clinical efficacy studies on a novel vaginal shield that would provide a full month of non-hormonal contraceptive activity. The protocol for the clinical trial is under development and the trial is planned to begin in Q4 2023. A Phase IIb trial of a novel hormonal male contraceptive gel is being evaluated in couples who agree to use the method for contraception. The trial is ongoing and preliminary results show high efficacy and acceptability of the product in both partners in the couple. The trial continues with completion scheduled for Q4 2024. A Phase IIa trial of a novel injectable contraceptive for women is being evaluated to find the optimal dose. The trial shows long-acting efficacy and high acceptability. The trial continues with dose escalation to determine duration of activity. Trial completion is scheduled for Q3 2024. Interactions with potential commercial partners is underway.

CDP使用研发合同来实现新方法开发的目标。该计划评估尚未上市的新药，这些新药必须根据现行的药品生产质量管理规范（cGMP）合成，并符合化学，生产和控制的所有监管标准。CDP拥有一个合同化学合成设施，以生产该计划所需的新药。潜在的新药物和设备需要毒理学测试来证明安全性。IND支持的临床前研究必须根据符合监管标准的药物非临床研究质量管理规范（GLP）进行。人体试验需要在cGMP下配制和释放药物，并进行涵盖试验持续时间的稳定性研究。CDP拥有一个生物试验机构，以进行首次人体研究和后期临床试验的长期毒理学研究所需的临床前评价和批次制备。 新产品的临床评价在CDP项目管理下的避孕临床试验网络（CCTN）中进行。CCTN评估新的避孕药物和设备对女性和男性的安全性和有效性。新实体的临床试验结果构成了通过开发推进候选药物和器械的基础，目标是获得FDA监管批准。CCTN由合格机构（包括国内和国际研究中心）的顶级临床研究人员组成，他们具有进行从首次人体试验到第三阶段避孕评估的所有阶段的专业知识。临床研究中心是下一代实地研究人员的培训基地。 新的合作研究与开发协议（CRADA）已于2021年谈判并获得批准。CRADA的目标是对一种新型阴道保护罩进行临床疗效研究，这种阴道保护罩将提供一个月的非激素避孕活性。临床试验的方案正在制定中，试验计划于二零二三年第四季度开始。 一种新型激素男性避孕凝胶的IIb期试验正在对同意使用该方法避孕的夫妇进行评估。该试验正在进行中，初步结果显示，该产品在夫妇双方中具有很高的疗效和可接受性。 试验继续进行，计划于2024年第四季度完成。 正在评估一种新型妇女注射避孕药的IIa期试验，以找到最佳剂量。该试验显示了长效有效性和高可接受性。试验继续进行剂量递增，以确定活性持续时间。试验计划于2024年第三季度完成。与潜在商业伙伴的合作正在进行中。