This study is looking at how a new cannabis compound with extremely low THC (0.08%), NTI164, is metabolised in the body and how it is excreted in urine over time (up to 28 days) in healthy adult volunteers. NTI164 will be delivered twice daily, at a concentration of 20mg/kg/day. There will be 2 parts to this study, Part A and Part B. Part A involves only one day of taking NTI164, whereas Part B involves taking NTI164 for 7 consecutive days. Urine samples and blood samples will be collected at certain time points after NTI164 dosing to help characterise how the drug is being broken down in the body and over what time frame.

开始日期2024-02-01

申办/合作机构

Fenix Innovation Group Pty Ltd

[+2]

NCT05268198

/ Completed早期临床1期

A Phase 1, Randomized, Blinded, Placebo-Controlled, First-in-Human, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of APR002 Administered by Inhalation in Healthy Volunteers

This study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of APR002 in healthy subjects.

开始日期2023-03-20

申办/合作机构

全球健康药物研发中心

[+2]

NCT04370431

/ Completed临床1期

A Phase I, Single Center, Randomized, Single-Ascending Dose, Pharmacokinetic and Safety Study (Part A), Bioavailability Comparison Study (Part B) and Food Effect Study (Part C) in Healthy Adult Subjects.

This is integrated Phase 1, Single centre, Randomized study will be conducted in 3 parts, each with a specific primary objective:
Part A: To characterise the safety and tolerability of TTYP01 in healthy adult subjects; Part B: To evaluate the bioavailability of TTYP01 tablets in healthy adult subjects; Part C: To characterise the food effect of TTYP01 tablets in healthy adult subjects under the fasted or fed condition.
The secondary objectives of the study are to evaluate the pharmacokinetic (PK) profiles of TTYP01 tablets in healthy adult subjects, and the effects of gender on the PK of TTYP01 tablets in healthy adults. In Part A of the study, a total of 32 healthy adult subjects will be enrolled over four consecutive cohorts (8 per cohort), with participants receiving a single dose of TTYP01 at one of four levels (60, 120, 10 or 240 mg), to assess the PK and safety of TTYP01. In Part B, 16 healthy adults will be randomized into 2 groups, and the comparison of the PK of edaravone (TTYP01 and intravenous (IV) edaravone) will be evaluated using a randomized, open-label, four-period crossover design under fasted conditions. In the first crossover period, subjects will receive a single fixed dose of TTYP01 followed by the alternate IV dose after completion of the washout phase, and in the second crossover period, subjects will receive a higher fixed dose of TTYP01 followed by the alternate IV dose after completion of the washout phase. In Part C, 18 healthy subjects will be enrolled to evaluate the effect of food on the PK of TTYP01 using a randomized, open-label, two-period cross-over design. Participants will be randomized into two groups and administered a fixed dose of TTYP01 on Day 1 (Period 1) under the fed conditions and the second dosing day (Period 2) under the fasted conditions, while the other group being administered a fixed dose of TTYP01 on Day 1 (Period 1) under the fasted conditions and the second dosing day (Period 2) under the fed conditions.

开始日期2020-04-24

申办/合作机构

苏州澳宗生物科技有限公司

[+2]

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项与 CMAX Clinical Research Pty Ltd. 相关的文献（医药）

2025-04-21·Cancer Research

Abstract 7300: Resolvin E1 in solid tumor cancer: towards clinical translation of a novel oral agonist targeting the LTB4-BLT1 pathway to sensitize tumors to immune checkpoint inhibition

作者: Jennings, Tracy ; Huang, Sui ; Panigrahy, Dipak ; Newman, Richard ; Klohs, Wayne D. ; Parkinson, John ; Steinberg, Joyce ; Mathias, Gary ; Paperiello, Beverly

AbstractBackground:Resolvin E1 (RvE1) and leukotriene B4 (LTB4) are both agonists of the BLT1 receptor (aka LTB4R1) but elicit distinct biological outcomes due to biased agonism. Activation of BLT1 promotes CD8+ T cell recruitment to the tumor, which enables effective immune checkpoint inhibitor (ICI) immunotherapy. However, LTB4, a pro-inflammatory lipid mediator, also promotes tumor progression through neutrophilic inflammation and is found at elevated levels in human cancers. In contrast, RvE1 selectively activates BLT1 to promote phagocytosis of tumor debris without causing inflammation. TP-317, a stabilized RvE1 molecule, effectively suppresses solid tumors in various murine models (CT26 colon carcinoma, Lewis lung carcinoma, B16F10 melanoma, KPCy pancreatic adenocarcinoma) when administered once daily, both alone and with ICI +/- chemotherapy. The effect of TP-317 as monotherapy required the presence of CD8 T cells and was largely abrogated in animals co-treated with a BLT1 antagonist. Whole-tumor transcriptomes of resected tumors of TP-317-treated versus control animals displayed broad upregulation of IFN-γ response genes and antigen presentation machinery, consistent with the synergism observed when given in combination with ICI. TP-317 is being developed as oral therapy for colorectal cancer and non-small cell lung cancer. The present study describes the pharmacokinetics, pharmacodynamics and safety profile of oral TP-317 given as an enteric-coated tablet to healthy volunteers.Methods:Twenty-four subjects were randomized 3:1 to single oral doses of TP-317 at 10, 40 and 80 mg (n=8/group). Safety, tolerability and PK/PD were assessed using standard methods. Subjects receiving the 80 mg dose underwent frequent CBC testing to assess short-term fluctuations in circulating neutrophils.Results:Oral TP-317 was well tolerated, achieving peak plasma concentrations of RvE1 that exceeded the EC50 for BLT1 activation (∼10 nM) by 1.2, 2.8, and 6.7 times at 10, 40, and 80 mg doses, respectively. All subjects receiving the 80 mg dose exhibited transient neutropenia, with neutrophil counts dropping below 1500/mL near plasma tmax and recovering to normal range within about 2 hours. A similar pattern, also without safety concerns, was previously observed in healthy subjects receiving an oral RvE1 drug (150 mg bid) for 10 days.Conclusions:Oral TP-317 demonstrates good tolerability and achieves adequate systemic RvE1 levels to engage the BLT1 receptor, suggesting a dose range of 40 to 80 mg once per day for patient studies. Transient neutropenia, a known effect of BLT1 activation by RvE1, indicates target engagement in humans. TP-317's unique ability to promote antigen presentation in myeloid and tumor cells offers a novel approach to sensitize tumors to ICI, warranting clinical investigation in cancer patients.Citation Format:Joyce Steinberg, Richard Newman, Beverly Paperiello, Tracy Jennings, Wayne D. Klohs, Sui Huang, Dipak Panigrahy, Gary Mathias, John Parkinson. Resolvin E1 in solid tumor cancer: towards clinical translation of a novel oral agonist targeting the LTB4-BLT1 pathway to sensitize tumors to immune checkpoint inhibition [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 1 (Regular Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_1):Abstract nr 7300.

2025-01-22·Journal of Crohn's and Colitis

P0627 Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of Oral Resolvin E1-based Therapy in Inflammatory Bowel Disease (IBD): Translating Resolvin E1 Activation of BLT1 in Experimental Models to Healthy Volunteers

作者: Siegmund, B ; Peyrin-Biroulet, L ; Parkinson, J ; Danese, S ; Jennings, T ; Jordan, D ; Steinberg, J ; Lipper, R ; Sands, B ; Newman, R ; Mathias, G ; Dubinsky, M ; Paperiello, B ; Guttendorf, R ; Verstockt, B ; Thomas, H

AbstractBackgroundResolvin E1 (RvE1), an endogenous lipid mediator, shows efficacy in murine colitis models by modulating mucosal immunity and protecting epithelial barrier function. RvE1 and leukotriene B4 (LTB4) are both BLT1 receptor agonists but elicit distinct biological outcomes through biased agonism. LTB4, a pro-inflammatory lipid mediator, initiates and regulates inflammatory responses by stimulating recruitment and activation of immune cells. In contrast, RvE1 selectively engages BLT1 to promote immune homeostasis and repair. TP-317, a stabilized RvE1 molecule, is being investigated as oral therapy for inflammatory bowel disease (IBD). In a sub-chronic murine model of DSS colitis, oral TP-317 (4.0 mg/kg) significantly improved disease activity and histological scores for mucosal inflammation and crypt loss. GLP toxicology studies in rats and dogs support TP-317’s safety profile, with the highest RvE1 doses tested in both preclinical species determined to be the no observed adverse event levels (NOAEL). This Phase 1a clinical study describes the pharmacokinetics (PK), pharmacodynamics (PD) and safety profile of TP-317 given as an enteric-coated tablet to healthy volunteers.MethodsTwenty-four subjects were randomized 3:1 to single oral doses of TP-317 at 10, 40 and 80 mg (n=8/group). Safety, tolerability and PK/PD were assessed using standard methods. Subjects receiving the 80 mg dose underwent frequent CBC testing to assess short-term fluctuations in circulating neutrophils.ResultsOral TP-317 was well tolerated, producing peak plasma RvE1 concentrations exceeding the EC50 for BLT1 activation (~10 nM) by 1.2, 2.8, and 6.7 times at 10, 40, and 80 mg doses, respectively. The mean AUC of the 80 mg group met regulatory requirements when compared to NOAEL dose exposures in rats and dogs. All 80 mg subjects experienced transient neutropenia, with neutrophils dropping below 1500/mL near RvE1 peak, followed by complete recovery above normal within ~2 hours. A similar pattern was previously observed without safety concerns in healthy subjects receiving an RvE1 drug at 150 mg twice daily for 10 days.ConclusionTP-317 demonstrates good tolerability and achieves adequate systemic RvE1 levels to engage the BLT1 receptor, offering a novel agonist approach to the LTB4-BLT1 pathway. Transient neutropenia observed with TP-317, a known effect of BLT1 activation by LTB4 and RvE1, suggests target engagement in humans. Oral TP-317’s safety profile and unique pro-resolution, barrier-protective mechanism warrant further clinical studies in IBD patients.

2025-01-01·Clinical Pharmacokinetics

Static Versus Dynamic Model Predictions of Competitive Inhibitory Metabolic Drug–Drug Interactions via Cytochromes P450: One Step Forward and Two Steps Backwards

Article

作者: Gardner, Iain ; Polasek, Thomas M ; Jamei, Masoud ; Heikkinen, Aki T ; Onasanwo, Anthonia ; Tiryannik, Ivan ; Rostami-Hodjegan, Amin

BACKGROUNDPredicting metabolic drug-drug interactions (DDIs) via cytochrome P450 enzymes (CYP) is essential in drug development, but controversy has reemerged recently about whether in vitro-in vivo extrapolation (IVIVE) using static models can replace dynamic models for some regulatory filings and label recommendations.OBJECTIVEThe aim of this study was to determine if static and dynamic models are equivalent for the quantitative prediction of metabolic DDIs arising from competitive CYP inhibition.METHODSDrug parameter spaces were varied to simulate 30,000 DDIs between hypothetical substrates and inhibitors of CYP3A4. Predicted area under the plasma concentration-time profile ratios for substrates (AUCr = AUC_{(presence of precipitant)}/AUC_{(absence of precipitant)}) were compared between dynamic simulations (Simcyp^® V21) and corresponding static calculations, giving an inter-model discrepancy ratio (IMDR = AUCr_dynamic/AUCr_static). Dynamic simulations were conducted using a 'population' representative and a 'vulnerable patient' representative with maximal concentration (C_max) or average steady-state concentration (C_avg,ss) as the inhibitor driver concentrations. IMDRs outside the interval 0.8-1.25 were defined as discrepancy between models.RESULTSThe highest rate of IMDR <0.8 and IMDR >1.25 discrepancies in the 'population' representative was 85.9% and 3.1%, respectively, when using C_avg,ss as the inhibitor driver concentration. Using the 'vulnerable patient' representative showed the highest rate of IMDR >1.25 discrepancies at 37.8%.CONCLUSIONStatic models are not equivalent to dynamic models for predicting metabolic DDIs via competitive CYP inhibition across diverse drug parameter spaces, particularly for vulnerable patients. Caution is warranted in drug development if static IVIVE approaches are used alone to evaluate metabolic DDI risks.

项与 CMAX Clinical Research Pty Ltd. 相关的新闻（医药）

2024-12-18

·Business Wire

Holoclara Initiates Phase 1 Clinical Trial Evaluating Worm-Derived Therapeutic HC002 in Healthy Adults

PASADENA, Calif.--( BUSINESS WIRE )--Holoclara, a biotechnology company pioneering the development of worm-derived therapies for allergic and autoimmune disorders, today announced the launch of a first-in-human Phase 1 clinical trial to evaluate the safety, tolerability, and pharmacokinetics of HC002 in healthy adults. HC002 is an investigational, orally bioavailable small molecule under development by Holoclara that is based on molecules identified in worms. “ Initiating our Phase 1 clinical trial for HC002 is more than a milestone for Holoclara — it is a first in humans and in medicine that could bring significant relief and benefit to the millions of patients suffering from chronic inflammatory diseases,” said Andrea Choe, M.D., Ph.D., co-founder and Chief Executive Officer of Holoclara. “ We are proud to bring a completely new type of medicine into the clinic — that harnesses molecules from worms, our natural partners who have co-evolved with humans and protected us from disease over millennia — and look forward to further progress on HC002 and our broader portfolio.” About the Phase 1 Trial Holoclara has completed its first Good Manufacturing Practice (GMP) batch of HC002, which will be used in the Phase 1 clinical trial. The randomized, double-blind, placebo-controlled, first-in-human dose escalation study will recruit healthy adult volunteers. HC002 will be administered orally. The trial is being conducted in Australia, where Holoclara has partnered with global clinical research organization Novotech and CMAX Clinical Research (CMAX), a leading clinical trial operator for early phase studies located in Adelaide, South Australia. CMAX will recruit and enroll participants and perform the study. Results are expected in 2025. “ The CMAX team are thrilled to partner with Holoclara to initiate the first-ever trials on the company’s breakthrough class of worm-derived medicines,” said Jane Kelly, Chief Executive Officer of CMAX Clinical Research. “ As one of Australia’s largest and most experienced clinical trial operators, CMAX is ideally suited to run early phase and first-in-human studies together with innovative biotechnology companies from around the world.” " Holoclara has brought into the clinic a totally novel, first-in-class technology that leverages extraordinary therapeutic attributes from worms and can make a global-reaching impact on how we treat inflammatory diseases," said Thomas Polasek, M.D., Ph.D., Associate Medical Director at CMAX and principal investigator for the study. “ We are proud to host Holoclara's first-in-human trial for HC002, which is a significant step towards putting breakthrough worm-derived therapies into the hands of patients around the world." Full details of the study are available at ClinicalTrials.gov . About Holoclara Holoclara is the first biotechnology company to create orally available, worm-derived therapies designed to provide relief to millions of people living with allergic and autoimmune disease. Co-founded and led by physician-scientist Andrea Choe, Holoclara mines immunomodulatory molecules from gut roundworms, building upon decades of preclinical data proving their therapeutic efficacy across a wide range of diseases. With a team of world-renowned experts in worm biology, experience in developing biotechnologies, and the backing of leading life sciences and technology investors, Holoclara is uniquely positioned to harness the therapeutic potential of worms to address historically untreatable diseases. To learn more, visit www.holoclara.com .

临床1期

2024-11-15

·GlobeNewswire-Health Care

Eccogene Announces Positive Phase 1 Data for Oral THR-β Full Agonist and Oral SSAO Inhibitor in Late-Breaking Poster Presentations at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting®

Both ECC4703 and ECC0509 demonstrated best-in-class potential, with favorable safety and tolerability profiles, clear target engagement and encouraging efficacy signalsBOSTON and SHANGHAI, Nov. 15, 2024 (GLOBE NEWSWIRE) -- Eccogene, a clinical-stage biopharmaceutical company developing next-generation oral small molecule therapeutics for chronic cardiometabolic and inflammatory conditions, today announced that two late-breaking abstracts on new Phase 1 data covering its novel oral THR-β full agonist (ECC4703) and oral SSAO inhibitor (ECC0509) will be reviewed in poster presentations at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting®. The congress is taking place November 15-19 in San Diego, California. “We are pleased that our Phase 1 results for ECC4703 and ECC0509 were selected as late-breaking abstracts at this premier medical congress – the first time human data for these programs will be publicly presented,” said Jingye Zhou, Chief Executive Officer of Eccogene. “Our Phase 1 results – which demonstrate favorable safety and tolerability profiles, PK and PD profiles supporting a once daily dose, and clear target engagement – highlight the potential for both candidates to be best-in-class molecules and provide the confidence needed to continue advancing these compounds into Phase 2 development.” Late-Breaking Poster Presentation Details: ECC4703 Title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ECC4703, a Highly Selective Liver Targeting Thyroid Hormone Receptor-beta (THR-β) Full Agonist for MASH (#5019)Session: Poster Session IV Date / Time: November 18, 2024 from 8:00 am - 5:00 pm PT Presenter: Dr. Sam Pak, PPD/AES, a part of Thermo Fisher Scientific Abstract Data Summary: ECC4703 exhibited a favorable safety and tolerability profileThe observed pharmacodynamic biomarker changes indicated clear target engagement, effectively lowering a panel of atherogenic lipids, with significant LDL reduction observed over 14 days of treatment ECC0509 Title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ECC0509, a SSAO Inhibitor for MASH (#5020)Session: Poster Session IV Date / Time: November 18, 2024 from 8:00 am - 5:00 pm PTPresenter: Dr. Angela Rowland, CMAX Clinical Research Pty Ltd Abstract Data Summary: ECC0509 demonstrated a favorable safety and tolerability profilePlasma SSAO activity was almost entirely inhibited by low doses of ECC0509, whereas plasma methylamine increased dose-dependently The abstracts for Eccogene’s poster presentations are now available on the AASLD website. The Company will make the posters available on its corporate website following the presentation session. About EccogeneEccogene is a clinical-stage biopharmaceutical company developing next-generation oral small molecule therapeutics for chronic cardiometabolic and inflammatory conditions. Since its founding, Eccogene has been dedicated to discovering safer and more effective oral therapies that can be used alone or synergistically with a GLP-1 receptor agonist to treat conditions beyond obesity. The Company’s diverse pipeline of small molecule candidates leverages its world-class expertise in translational research, small molecule discovery, and a deep understanding of diabetes, weight loss and cardiometabolic disease pathways. Eccogene’s oral small molecule GLP-1 receptor agonist, ECC5004, is a potentially best-in-class asset. ECC5004 was licensed to AstraZeneca and Eccogene retains the rights to co-develop and co-commercialize in China. The Company also has clinical programs underway that target THR-β and SSAO, as well as preclinical programs targeting proven pathways, such as GIP. For more information, please visit www.eccogene.com or follow the Company on LinkedIn. Media Contact Amy Bonanno Lyra Strategic Advisory abonanno@lyraadvisory.com

临床1期临床结果AACR会议

2023-10-23

·研发客

澳洲临床研究中心分享：如何快速招募患者 | 第一现场

// 澳洲临床研究项目启动后，仍需要中国药企与当地服务商紧密配合，确保研究可以高效地执行。澳洲的CRO公司、临床研究中心向研发客分享了一些经验和建议。为了更顺利地在澳大利亚启动临床试验，绝大多数中国药企都会提前与一些服务商，包括CRO公司、临床研究中心、临床实验室检测服务和法规服务提供商取得联系，做好充足的准备。拓展阅读去澳洲做临床，需要哪些准备？不仅如此，在项目的执行过程中，中国药企同样需要与当地服务商紧密联系和配合，采取各种方式规避并降低风险，以保证临床研究的高效快速和高质量执行。想了解更多澳大利亚早期临床试验相关资讯可发邮件至javen.li@austrade.gov.au联系澳大利亚驻沪总领馆商务处李先生或扫描下方二维码访问网站并下载资料提前了解研究申请的法规和流程虽然整体上，澳大利亚的临床试验遵循ICH的GCP指南，但实际操作上，有很多当地的法律法规需要遵守。因此在启动临床前，了解和熟悉当地的法规，有助于研究的顺利开展。科越医药中国和亚洲区研发与运营总裁闫慧告诉研发客，该公司在实际操作时，主要是通过CRO公司来了解和处理当地法规问题。德琪医药临床运营副总裁孙士敏同样表示，该公司在法规问题上，主要是通过CRO公司来了解，“在项目启动前，CRO公司会将相关的法规和我们讲一下，帮助我们遵守”。此外，当地员工也能给予一些反馈。专注于癌症早期研究的跨国CRO公司Syneos Health介绍，在澳大利亚，临床试验有两种监管途径：一种是适用于大多数研究的临床试验通知（CTN）机制，另一种是针对高风险或某些新药（缺少足够的科研数据和研究的创新药物），在需要时进行全面监管审查的临床试验批准（CTA）机制。Syneos Health建议中国企业最好与CRO联系以获得关于当地法规方面的各种支持。澳大利亚唯一的独立第三方伦理机构Bellberry介绍了在澳大利亚开展临床试验的伦理审批流程。人类研究伦理委员会（HREC）的审批活动，需按照“人类研究道德行为国家声明”（简称“国家声明”）的指南进行。按照“国家声明”，HREC的成员包括一名委员会主席、多名专业和非专业人士组成的审评员以及来自来自社区、法律界以及教牧关怀方面的代表。每个HREC都是根据提交申请的研究所需的专业知识量身定做，规定的委员会人数也根据每次研究而有所不同。通常来说，还应该确保每项研究有多名科学专家对特定研究阶段和治疗领域进行审查。申办方需要将临床试验申请和所需要的文件一并提交给HREC。Bellberry介绍，若通过该机构审查，申办方可以在线注册后通过eProtocol系统提交申请。在线申请包括一份简短的表格，并附上相关文件。HREC的审查包括有科学和伦理审查。Bellberry每周都会举行HREC会议，议程会在两周前准备好，会议反馈会在会议后两天内提供给申办方。通常，HREC会提出一系列的问题来澄清问题，或要求申办方提供更多的信息，以简化审查过程。如果研究符合所有的科学和伦理要求，就能获得批准。HREC提出的问题取决于所申请的研究情况及提交文件。可能的一些关键问题包括：支持研究的临床前数据不充分，研究设计未明确描述研究目标或与研究目标不符，参与者信息和知情同意书提供的信息不充分，或者没有使用通俗的语言让参与者理解研究的要求。采取多种方式招募患者受试者招募和入组直接关系到临床试验的启动和项目进度，也是研究执行中的关键点和难点。澳大利亚的各家私立临床研究中心都采取各种方式来加速这个过程。专注于健康受试者早期临床试验的澳大利亚研究中心CMAX Clinical Research介绍，该中心成立30年来，已有一支专门的市场团队通过各种方法来招募健康受试者。比如，在社交媒体、广播、印刷出版物以及公交站等发布广告，以及与当地的全科医生（GP）合作。此外，CMAX还拥有一个数据库，里面有超过4.7万名健康志愿者的信息。相对于健康受试者，患者的招募更为复杂和困难。在采访中，德琪医药的孙士敏表示，药物新颖、研究方案创新的项目相对来说更受到澳大利亚研究者的欢迎，也更愿意推荐患者。百济神州该公司高级副总裁、全球研发负责人汪来博士则提到了疾病的选择，“选择澳大利亚发病率较高的癌症，如黑色素瘤，患者较多，入组就相对容易”。Cancer Research South Australia (CRSA) 和Southern Oncology Clinical Research Unit（SOCRU）是专门针对癌症的临床研究中心。其中，CRSA开展1~3期研究，而SOCRU仅专注于早期阶段的研究。这两家研究中心都向研发客分享了他们如何设法快速地招募患者。CRSA和SOCRU都提到，他们会每月一次与所处州的肿瘤医生分享正在开展的研究，并将相关研究在网上发布。CRSA还会将所有的研究项目与多学科团队的所有成员共享，以加快患者招募。SOCRU提到，该中心还会直接与患者组织联系，告知可适用的试验，提高他们对临床试验的认识。他们建议中国公司在积极配合研究中心的同时，也可以寻找多种方式来增加研究的曝光度，让受试者主动过来联系。来自临床研究中心的建议这些临床研究中心还提到如何高效地完成项目启动以及知情同意、访视安排等工作。研发客采访的多家临床研究中心均建议申办方在临床前研究进入到研究期时，就应该尽早与研究中心联系。CMAX的CEO Jane Kelly表示，临床研究中心从申办方及早获得有关研究方案和时间规划的反馈意见，可以提前预留和调整排期，并就科学方面和研究方案给出修改建议，确保方案可以在获得HREC审查批准后顺利进行。另外，申办方最好要确保研究方案有足够的背景信息，例如药物信息和安全性数据，以便PI 能尽可能了解研究的审查情况，并在提交 HREC申请之前就准备好可能的方案调整。CRSA的中心主任Rohit Joshi提到，在研发方案撰写阶段就与他们联系，可以帮助申办方设计的方案符合澳大利亚治疗和实践标准。SOCRU承诺会在研究方案最终确定前将反馈意见告知申办方，以确保能在研究启动前确定访视和给药时间表。该中心特别指出，方案一旦确定，访视和给药时间表就很难更改，因此尽早与他们联系，听取他们给出的建议就显得非常重要。另外，SOCRU还实施了远程知情同意的流程，让这个过程更加高效，特别是方便了居住在边远地区的受试者，他们无需亲自前来就可以完成知情同意。当然，要确保项目的快速启动和高效执行，除了研究中心以外， CRO和申办方的项目经验和风险管理策略也很重要。在澳洲做临床样本分析也有税务激励国内药企在澳大利亚开展的大多是1期临床研究。而早期研究通常需要频繁采集临床样本，获取大量的药代动力学（PK）和药效学（PD）数据。这些数据对于后面的安全性研究、剂量探索和临床决策都至关重要。因此，选择一个合规且富有经验的生物样本分析实验室对于临床试验的高质量完成也非常关键。在采访中，研发客发现，多数中国公司将简单的生化检测以及对时间要求高的样本检测放在澳大利亚当地实验室进行，而其他一些对时间要求不高的检测会选择将样本寄回国或者其他地区的中心实验室来检测。不过，也有一些中国公司会选择将PK、PD检测都放在澳大利亚当地完成，以更快地获得符合FDA、EMA等国际监管机构认可的数据。Agilex Biolabs 在接受采访时表示，中国公司可以根据自身实际情况，考虑更多地使用澳大利亚当地的实验室分析服务。该实验室成立于1996年，是澳大利亚最大、技术最先进的受监管生物分析和毒理学实验室，能提供大分子和小分子药物的生物检测分析服务。当前，该公司客户中12%~30%为中国公司。Agilex 提到，中国药企选择在澳大利亚本地开展临床样本分析，与临床试验一样，可以享受到相应的研发税务激励政策。此外，在保证质量的情况下速度更快。例如，Agilex的实验室就获得了ISO/IEC17025 认证、 OECD GLP 认可以及澳大利亚NATA相关认证，符合FDA和EMA等国际监管机构的要求，且报告的数据都经过质控。对于小分子药物，Agilex 可以在 3 个工作日内提供单次给药剂量递增(SAD) 研究的质控后数据，并在 4 个工作日内提供多次给药剂量递增(MAD) 研究的质控后数据。Agilex表示，凭借训练有素、经验丰富的专业科学家团队，处理复杂的临床样本的生物分析，特别是救援研究（rescue study）更是Agilex独特的优势。他们曾成功地挽救了多起即将被宣判失败的临床试验，包括失败的实验方法学的建立、迫在眉睫的 FDA/EMA 提交期限或已被其他实验室宣告放弃的研究。澳州的CDMO资源为了在澳大利亚进行临床试验，中国药企通常还需要将在国内生产的药品运送到澳大利亚。对此，Syneos建议，药企在运送样本和药品前，需要了解相关的法规和政策。例如，运输药品需要了解检疫限制和禁运药品表。另一方面，尽管极少有中国公司选择澳大利亚本土的生产服务，但研发客在采访中了解到，澳大利亚还是有一些具有丰富经验的CDMO。例如，位于南澳大利亚州的Mayne Pharma就是一家可以提供全方位服务的CDMO，有着40多年的商业化生产和分析开发经验，专注于生产新型口服和外用剂型，包括喷雾干燥粉末、硬胶囊和片剂、双层口服药物、缓释控释速释剂型以及液体、悬液剂、霜剂、软膏剂和鼻喷雾剂等。Mayne提到，选择澳大利亚本土的生产服务，可以享受到澳大利亚政府的各种研究激励措施，而他们也有能力提供从1期临床研究到商业化生产的全套制剂开发和生产，并拥有FDA和澳大利亚TGA认证。另外，BioCina是一家生物制剂CDMO，专门开展以微生物为基础的疗法的工艺开发和符合cGMP的生产，可开展微生物发酵、质粒DNA和mRNA疫苗的临床开发和商业化生产服务。过去15年里，该公司已经成功开发和生产了50多种产品，并成功实施了多次技术转移。如需了解更多澳州临床试验的信息，欢迎持续留意研发客。编辑 | 姚嘉yao.jia@PharmaDJ.com 总第1982期访问研发客网站可浏览更多文章www.PharmaDJ.com

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