A Double-Blinded, Placebo-controlled, Double Dummy, Multi-center Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on One to Three Glucose-lowering Agents

ORA-013-3 is a randomized, controlled study to test the efficacy and safety of an oral capsule of ORMD-0801 at several doses in patients with Type 2 Diabetes Mellitus (T2DM) who have not responded well to other glucose-lowering medications. A total of three hundred subjects will be enrolled in this study and will be required to complete this thirty-four-week clinical trial.

开始日期2025-03-15

申办/合作机构

Oramed Ltd.

[+1]

NCT06334211 / Completed临床1期

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single-center, Single and Multiple Ascending Oral Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of FP-020 in Healthy Volunteers

This is a study to Investigate the Safety, Tolerability, and Pharmacokinetics, of Single (including Food Effect) and Multiple Ascending Doses of FP-020 in Healthy Adult Volunteers.

开始日期2024-04-16

申办/合作机构

逸达生物科技股份有限公司

[+1]

NCT05607004 / Recruiting临床2期

A Randomized Phase 2 Non-inferiority Trial of (Z)-Endoxifen and Exemestane + Goserelin as Neoadjuvant Treatment in Premenopausal Women With ER+/HER2- Breast Cancer

This open-label research study is studying (Z)-endoxifen as a possible treatment for pre-menopausal (still having periods) women with ER+/HER2- breast cancer. (Z)-endoxifen is a selective estrogen receptor modulator or "SERM." SERMs work to treat cancer by blocking the body's natural estrogen from binding to cancer cells. This study includes a pharmacokinetic part (PK, how the drug works in your body) and a treatment part. The primary purpose of the study is to see how (Z)-endoxifen works on tumor cell growth by monitoring a cancer marker called Ki-67. Ki-67 will be measured by biopsy of the breast after about 4 weeks of treatment. If your cancer is responding to treatment based on the Ki-67 results, you may continue treatment up to 24 weeks or until surgery.
The PK part of the study will be enrolled first, enrolling about 18 study participants who will all receive oral once daily (Z)-endoxifen treatment. 12 of these participants will be randomly assigned to treatment with an equal (50/50) chance to be assigned to (Z)-endoxifen or (Z)-endoxifen + goserelin (a medication given to block the ovaries from making estrogen and is also called ovarian suppression). This part of the study will help select the dose of (Z)-endoxifen to use in the treatment part by measuring the levels of (Z)-endoxifen in the blood stream and determine how long it takes for the body to remove it.
About 160 study participants will be enrolled in the treatment part. The treatment part will help to determine how oral once daily (Z)-endoxifen, when taken by itself, compares to oral once daily exemestane (a medication that decreases the amount of estrogen in the body, also known as an aromatase inhibitor) and monthly injections of goserelin. Exemestane and goserelin taken together is a standard treatment regimen for premenopausal patients with ER+/HER2- breast cancer. Study participants are randomly assigned to treatment with an equal (50/50) chance to be assigned to (Z)-endoxifen or standard treatment.
Study participation is up to 24 weeks of treatment followed by surgery.

开始日期2023-02-14

申办/合作机构

Atossa Therapeutics, Inc.

[+1]

100 项与 Inclin, Inc. 相关的临床结果

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项与 Inclin, Inc. 相关的文献（医药）

2016-08-01·American journal of obstetrics and gynecology1区 · 医学

Assessment of a cervicometer compared to transvaginal ultrasound in identifying women with a short cervical length: a multicenter study

1区 · 医学

Article

作者: Hoffman, Matthew K ; Cebrik, Deb ; Kivel, Frances J ; Paidas, Michael J ; Baxter, Jason K ; Adair, C David ; Ross, Michael G

BACKGROUND:

Preterm birth remains a major cause of neonatal morbidity and mortality worldwide. Short cervical length (CL) as measured by transvaginal ultrasound (TVU) in the second trimester represents the single most predictive risk factor for spontaneous preterm birth. Previous studies have addressed, in part, the limitations of TVU availability by utilizing a cervicometer to screen patients for short cervix, identifying those patients who may not benefit from TVU CL screening. In view of the prior studies indicating that a cervicometer measurement may have a high negative predictive value (NPV) for a sonographically short cervix, we sought to identify the ideal cervicometer threshold value in a prospective, multicenter study.

OBJECTIVE:

The primary objective was to determine the cervicometer CL measurement threshold that provides a high NPV for the identification of patients who are highly unlikely to have a TVU CL measurement ≤20 and ≤25 mm and, therefore, may forego TVU.

STUDY DESIGN:

This prospective study, executed in 5 US centers, included 401 women ≥18 years of age who provided written informed consent to undergo CL measurement in the mid trimester. All women underwent both cervicometer- and TVU-measured CLs by individuals blinded to results of the other measurement. Both measurements were performed at 17-23 weeks' gestation (visit 1) and repeated at 24-29 weeks' gestation (visit 2). All TVU measurement images were reviewed by a central reader. Test characteristics and receiver operating characteristic curves were created to determine and confirm the optimal cervicometer CL threshold, maximizing the NPV.

RESULTS:

In all, 358 subjects were evaluable at visit 1 and 267 at visit 2. At visit 1, the average TVU CL was 38.7 ± 7.6 mm and the average cervicometer CL was 30.3 ± 8.8 mm. Similar measurements were seen at visit 2. Receiver operating characteristic curves were utilized to graphically identify a cervicometer CL threshold of 30 mm that maximized sensitivity while minimizing the false-positive rate. The 30-mm cervicometer CL threshold provided a 98-100% NPV and 0.0 negative likelihood ratio for identification of women who have a low likelihood to have a sonographic short cervix (ie, transvaginal CL ≤20 mm or ≤25 mm). The 17-23 weeks' gestation 30-mm cervicometer CL threshold has 100% sensitivity, 45-46% specificity, and 1.8 and 0.0 positive and negative likelihood ratios to predict sonographic CL ≤20 and ≤25 mm.

CONCLUSION:

Cervicometer CL screening successfully identifies women at low risk for short transvaginal CL. Use of a 30-mm threshold by cervicometer CL measurement confers a 98-100% NPV, with high sensitivity and moderate specificity to predict a TVU short CL. Cervicometer measurement of CL may permit almost 50% of women to avoid TVU.

2015-02-01·Antimicrobial agents and chemotherapy2区 · 医学

Analysis of the Phase 3 ESTABLISH Trials of Tedizolid versus Linezolid in Acute Bacterial Skin and Skin Structure Infections

2区 · 医学

Article

作者: De Anda, Carisa ; Corey, G. Ralph ; Shorr, Andrew F. ; Fang, Edward ; Prokocimer, Philippe ; Das, Anita F. ; Lodise, Thomas P.

ABSTRACT:

Tedizolid, a novel oxazolidinone with activity against a wide range of Gram-positive pathogens, was evaluated in two noninferiority phase 3 acute bacterial skin and skin structure infection trials. The data from individual trials showed its noninferior efficacy compared to that of linezolid and a favorable tolerability profile. To evaluate potential differences, the pooled data were analyzed. The patients received 200 mg of tedizolid once daily for 6 days or 600 mg of linezolid twice daily for 10 days. Efficacy was evaluated at 48 to 72 h (primary endpoint), on days 11 to 13 (end of therapy [EOT]), and 7 to 14 days after the EOT (posttherapy evaluation). Treatment-emergent adverse events and hematologic and clinical laboratory parameters were collected. The baseline characteristics were comparable between the treatment groups: 852/1,333 (64%) patients were from North America, and the majority of infections were caused by Staphylococcus aureus . Tedizolid was noninferior to linezolid (early clinical responses, 81.6% versus 79.4%, respectively). The early responses remained relatively consistent across various host/disease factors and severity measures. Nausea was the most frequently reported adverse event (tedizolid, 8.2%; linezolid, 12.2%; P = 0.02), with onset occurring primarily during the first 6 days. Fewer tedizolid than linezolid patients had platelet counts of <150,000 cells/mm 3 at the EOT (tedizolid, 4.9%; linezolid, 10.8%; P = 0.0003) and during the postbaseline period through the last day of active drug visit (tedizolid, 6.4%; linezolid, 12.6%; P = 0.0016). Efficacy was achieved with a 6-day once-daily course of therapy with the option of an intravenous/oral regimen, and fewer low platelet counts and gastrointestinal side effects were reported with tedizolid than with linezolid, all of which aligns well with antimicrobial stewardship principles. (These studies have been registered at ClinicalTrials.gov under registration no. NCT01170221 and NCT01421511.)

2013-06-01·Antimicrobial agents and chemotherapy2区 · 医学

Randomized, Double-Blind, Multicenter Phase 2 Study Comparing the Efficacy and Safety of Oral Solithromycin (CEM-101) to Those of Oral Levofloxacin in the Treatment of Patients with Community-Acquired Bacterial Pneumonia

2区 · 医学

Article

作者: Jamieson, Brian D. ; Scott, Drusilla ; Das, Anita ; Clark, Kay ; Fernandes, Prabhavathi ; Oldach, David ; Craft, J Carl ; Schranz, Jennifer

ABSTRACT:

Solithromycin, a new macrolide, and the first fluoroketolide in clinical development, with activity against macrolide-resistant bacteria, was tested in 132 patients with moderate to moderately severe community-acquired bacterial pneumonia (CABP) in a multicenter, double-blind, randomized phase 2 study. Patients were enrolled and randomized (1:1) to either 800 mg solithromycin orally (PO) on day 1, followed by 400 mg PO daily on days 2 to 5, or 750 mg levofloxacin PO daily on days 1 to 5. Efficacy outcome rates of clinical success at the test-of-cure visit 4 to 11 days after the last dose of study drug were comparable in the intent-to-treat (ITT) (84.6% for solithromycin versus 86.6% for levofloxacin) and microbiological-intent-to-treat (micro-ITT) (77.8% for solithromycin versus 71.4% for levofloxacin) populations. Early response success rates at day 3, defined as improvement in at least two cardinal symptoms of pneumonia, were also comparable (72.3% for solithromycin versus 71.6% for levofloxacin). More patients treated with levofloxacin than with solithromycin experienced treatment-emergent adverse events (TEAEs) during the study (45.6% versus 29.7%). The majority of TEAEs were mild or moderate gastrointestinal symptoms and included nausea (1.6% for solithromycin; 10.3% for levofloxacin), diarrhea (7.8% for solithromycin; 5.9% for levofloxacin), and vomiting (0% for solithromycin; 4.4% for levofloxacin). Six patients, all of whom received levofloxacin, discontinued the study drug due to an adverse event. Solithromycin demonstrated comparable efficacy and favorable safety relative to levofloxacin. These findings support a phase 3 study of solithromycin for the treatment of CABP. (This study has been registered at ClinicalTrials.gov under registration no. NCT01168713.)

项与 Inclin, Inc. 相关的新闻（医药）

2023-04-25

·BioSpace

Lexaria Awards CRO Contract for Upcoming U.S. Phase 1b Hypertension Study

Clinical study will evaluate safety and tolerability of Lexaria's patented DehydraTECH-CBD as a potential treatment for hypertension California-based InClin to provide CRO services to manage and expedite the study Lexaria is working with its regulatory and clinical advisors toward upcoming IND submission KELOWNA, BC / ACCESSWIRE / April 24, 2023 / Lexaria Bioscience Corp. (Nasdaq:LEXX)(Nasdaq:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces it has awarded the contract for clinical research organization ("CRO") services for its expected upcoming Food and Drug Administration ("FDA")-registered, U.S. Phase 1b Investigational New Drug ("IND") hypertension study HYPER-H23-1 with its patented DehydraTECH-powered cannabidiol ("DehydraTECH-CBD") to California-based InClin, Inc. Study HYPER-H23-1 is entitled 'A Phase 1b Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Pharmacokinetics, and Pharmacodynamics of DehydraTECH-CBD in Subjects with Stage 1 or Stage 2 Hypertension' . The primary objective of the study will be to evaluate safety and tolerability in 120 hypertensive patients, and secondary objectives will include efficacy evaluation in reducing blood pressure together with detailed pharmacokinetic testing. InClin is about to begin study start-up and preparatory activities to enable Lexaria to "hit the ground running" with patient dosing as soon as possible after the expected FDA IND filing and review is completed. Lexaria anticipates filing the IND this summer with hoped-for FDA authorization within about 60 days, resulting in the Phase 1(b) trial aggressively targeting commencement of patient dosing as early as October 2023. The study start-up services to be provided by InClin include but are not limited to: clinical site evaluation and selection, personnel and site training, project management, clinical database design and management, quality assurance support, medical writing, study documentation creation, biostatistics and programming, support vendor coordination, Independent Review Board ("IRB") submissions and more. Lexaria had a successful outcome following its FDA pre-IND meeting as announced on August 10, 2022. Since then, the Company has been working tirelessly with its regulatory and clinical advisors on refining the study plan and preparing for the IND submission pursuant to the pre-IND guidance it received from the FDA. The Company is in the process of performing the drug product manufacturing and stability testing required as part of the upcoming IND submission, compliant with current Good Manufacturing Practice ("cGMP") regulations. Assembling the stability data from its cGMP-manufactured batch production work is one of the last requirements prior to Lexaria submitting its formal IND application to the FDA this summer. Lexaria's five previous human clinical studies conducted from 2018 through 2022, which were not conducted under FDA-registration but are expected to be integral to successful filing and review of its upcoming IND submission, were carried out in an aggregate total of 134 healthy and hypertensive persons. These foundational studies evidenced significant reductions in resting blood pressure over both acute and multi-week dosing regimens, and also produced zero serious adverse events; suggesting that DehydraTECH-CBD has the potential to have pronounced clinical benefits relative to available anti-hypertensive therapeutics. Lexaria is aware of only a handful of other published research studies, mostly in young, healthy and normotensive volunteers, that have investigated whether a sustained decrease in resting blood pressure is possible following multiple weeks of oral CBD dosing; none of which have been successful in achieving this. DehydraTECH-CBD is currently unique in its evidenced superior power to reduce blood pressure over other oral CBD formulations. Findings from Lexaria's latest study HYPER-H21-4 demonstrated a potentially novel mechanism of action of DehydraTECH-CBD in reducing blood pressure which may be explained, at least in part, by its interaction with the human sympatho-chromaffin system via catestatin modulation as detailed in the peer-reviewed and published respected journal, " Biomedicine and Pharmacotherapy ". This is of significance because the FDA has previously laid out clear guidelines for sponsors who seek to develop new anti-hypertensive drugs, specifically defining the need for medications that offer novel and complementary modes of action. Data gathered from study HYPER-H21-4 suggested that DehydraTECH-CBD had the potential to offer additive blood pressure reduction benefits on top of any degree of improvements that standard of care medications achieved for patients prior to DehydraTECH-CBD dosing. About DehydraTECH-CBD DehydraTECH-CBD is a unique CBD formulation Lexaria has developed and is optimizing based on its patented and proprietary DehydraTECH drug delivery technology. DehydraTECH is designed to improve the way active molecules enter the bloodstream upon oral ingestion. DehydraTECH has also demonstrated enhanced delivery of certain active molecules including CBD into brain tissue, which Lexaria believes to be of particular importance for the effectiveness of its DehydraTECH-CBD specifically against hypertension because of the significant influence of central mediation upon blood pressure. Lexaria has also developed DehydraTECH-CBD formulations for other applications demonstrating superior bio-absorption when administered intraorally and topically. About InClin, Inc. InClin is a full-service Contract Research Organization (CRO) with offices in the San Francisco Bay Area and Sydney, Australia. They are a single source provider of an integrated full suite of clinical development services from Phase 1 to Phase 4, including project management, clinical monitoring, site and contract management, vendor management, data management, biostatistics, programming, drug safety, medical monitoring, medical writing, QA inspection readiness, and strategic consulting services. InClin has assembled a team of seasoned professionals and vendor service providers who will support study HYPER-H23-1 for Lexaria, with extensive expertise and experience in the core areas relevant for this program including cardiac safety and efficacy monitoring and pharmacokinetic testing. For more information visit . About Lexaria Bioscience Corp. Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids, antiviral drugs, PDE5 inhibitors and more. DehydraTECH has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 30 patents granted and many patents pending worldwide. For more information, please visit . CAUTION REGARDING FORWARD-LOOKING STATEMENTS This press release includes forward-looking statements. Statements as such term is defined under applicable securities laws. These statements may be identified by words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions. Such forward-looking statements in this press release include, but are not limited to, statements by the company relating the Company's ability to carry out research initiatives, receive regulatory approvals or grants or experience positive effects or results from any research or study. Such forward-looking statements are estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that the Company will actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements. As such, you should not place undue reliance on these forward-looking statements. Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, government regulation and regulatory approvals, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Company's ability to maintain existing collaborations and realize the benefits thereof, delays or cancellations of planned R&D that could occur related to pandemics or for other reasons, and other factors which may be identified from time to time in the Company's public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR. The Company provides links to third-party websites only as a courtesy to readers and disclaims any responsibility for the thoroughness, accuracy or timeliness of information at third-party websites. There is no assurance that any of Lexaria's postulated uses, benefits, or advantages for the patented and patent-pending technology will in fact be realized in any manner or in any part. No statement herein has been evaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat, cure or prevent any disease. Any forward-looking statements contained in this release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements or links to third-party websites contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law. INVESTOR CONTACT: George Jurcic - Head of Investor Relations ir@lexariabioscience.com Phone: 250-765-6424, ext 202 SOURCE: Lexaria Bioscience Corp. View source version on accesswire.com:

临床1期临床申请

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