[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Amckaus PTY LTD.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":76},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":4},"100644878","phase-2-aom0304-in-adult-patients-with-symptomatic-hypertrophic-cardiomyopathy-100644878",false,"NCT07675668","Aom0304 in Adult Patients With Symptomatic Hypertrophic Cardiomyopathy","A Phase 2, Multi-Regional, Open-label, Three-Part Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Aom0304 in Adult Patients With Symptomatic Hypertrophic Cardiomyopathy","Inclusion Criteria:\n\n1. Able to understand and comply with the study procedures, understand the risks involved in the study, and provide written informed consent according to federal, local, and institutional guidelines before the first study-specific procedure.\n2. Men or women participants aged 18 to 70 years (both inclusive) at Screening.\n3. Documented diagnosed with HCM based on European Society of Cardiology\u002FAmerican College of Cardiology Foundation criteria: hypertrophied and non-dilated left ventricle in absence of other systemic or cardiac causes, with left ventricular wall thickness ≥ 15 mm at diagnosis or ≥ 13 mm with a positive family history of HCM, or a known gene mutation related to HCM.\n4. Participants who are already treated with β-blockers, verapamil, diltiazem, or ranolazine should have been on stable doses for at least 4 weeks prior to Day 1 and anticipate remaining on the same medication regimen during the study.\n5. Body weight must be ≥ 45 kg and body mass index 18 to 35 kg\u002Fm2 (both inclusive) at Screening.\n6. LVEF ≥ 60% at Screening.\n7. Symptomatic HCM defined as NYHA functional Class II or III at Screening.\n8. Part-specific requirements at Screening:\n\n   * Part 1: Post-Valsalva LVOT-G ≥ 30 mmHg and \\\u003C 50 mmHg.\n   * Part 2: Resting LVOT-G ≥ 50 mmHg or resting ≥ 30 mmHg with post-Valsalva ≥ 50 mmHg.\n   * Part 3: Resting\u002Fpost-Valsalva or exercise LVOT-G \\\u003C 30 mmHg with NT-proBNP \\> 300 pg\u002FmL.\n9. Have adequate acoustic windows for accurate TTEs.\n10. Female participants must not be pregnant or lactating and if sexually active, must be using 1 of the following acceptable contraceptive methods from the Screening through 3 months after the last dose of the study drug. Hormonal contraceptives are not considered highly effective contraceptive methods for this study. Acceptable contraceptive methods are listed as below.\n\n    * Double-barrier method (eg, vasectomy or male using a condom and female using a diaphragm or cervical cap).\n    * Barrier (eg, male using a condom) plus non-hormonal intrauterine device or intrauterine system.\n    * Females are surgically sterile for 6 months or postmenopausal for 2 years. Permanent sterilisation includes hysterectomy, bilateral oophorectomy, bilateral salpingectomy, and\u002For documented bilateral tubal occlusion at least 6 months prior to Screening.\n\n    Females are considered postmenopausal if they have had amenorrhea for at least 2 years or more following cessation of all exogenous hormonal treatments and follicle-stimulating hormone (FSH) levels are ≥ 40 IU\u002FL at Screening (confirmed by at least 2 separate occasions during Screening Period).\n11. Male participants with female partners (including postmenopausal partners) must agree to use highly effective contraceptive measures. from the Screening through 3 months after the last dose of study drug. Highly effective contraception is presented in Inclusion criterion #10.\n\n    As there may be a risk of drug being secreted in the ejaculate, male participants (including men who have had vasectomies) whose partners are currently pregnant, or not pregnant or capable of becoming pregnant, should use barrier methods for the duration of the study and 3 months following the last dose of study drug in order to prevent passing Aom0304 to the partner in the ejaculate.\n12. Male and female participants must agree to not donate sperm or ova after the first dose of study drug until at least 3 months following last dose of study drug.\n13. Must be able to complete the Dyspnoea Numeric Rating Scale (NRS) and the KCCQ per established guidelines.\n14. Participants must be able to safely undergo CPET at Baseline and follow-up.\n\nExclusion Criteria:\n\n1. Participants with clinically significant haematology or chemistry abnormalities at Screening, as determined by the Investigator, including but not limited to:\n\n   * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 3 × upper limit of normal (ULN).\n   * Total bilirubin \\> 2 × ULN.\n   * Haemoglobin \\\u003C 9 g\u002FdL.\n   * Platelet count \\\u003C 100000\u002FµL.\n   * Estimated glomerular filtration rate (eGFR) \\\u003C 30 mL\u002Fmin\u002F1.73m².\n2. Known hypersensitivity to Aom0304, or any of the components of the formulation of Aom0304, or alcohol.\n3. History of sustained ventricular tachyarrhythmia or cardiac arrest.\n4. Implanted cardioverter defibrillator (ICD) placement within 3 months prior to Screening or planned ICD placement during the study.\n5. History of myocardial diseases other than HCM, including but not limited to: myocarditis, ischemic cardiomyopathy, dilated cardiomyopathy, cardiac amyloidosis, restrictive cardiomyopathy, Takotsubo syndrome, arrhythmogenic right ventricular cardiomyopathy.\n6. Poor controlled hypertension, defined as systolic blood pressure (BP) ≥ 160 mmHg or diastolic BP ≥ 100 mmHg at Screening or Baseline despite stable antihypertensive therapy.\n7. Participants who have been treated with septal reduction therapy (surgical myectomy or percutaneous alcohol septal ablation) or have plans for either treatment during the study period.\n8. History of syncope with exercise within past 6 months prior to Screening.\n9. Active infection, defined as any acute bacterial, viral, or fungal infection of any organ system (eg, respiratory, urinary, gastrointestinal, skin\u002Fsoft tissue, cardiovascular, or central nervous system) requiring systemic antimicrobial therapy or considered to be clinically significant by the Investigator.\n10. Current or recent (within 3 months prior to Screening) treatment with cardiac myosin inhibitors (eg, mavacamten, aficamten).\n11. Persistent atrial fibrillation (AF), or paroxysmal AF with resting heart rate (HR) \\> 100 bpm within 1 year prior to Screening.\n12. Have QT interval corrected by Fridericia's (QTcF) formula \\> 500 ms, or any other ECG abnormality considered by the Investigator to pose a risk to participant safety (eg, second degree atrioventricular block type II).\n13. Aortic stenosis or fixed subaortic obstruction.\n14. History of left ventricular systolic dysfunction (LVEF \\\u003C 45%).\n15. History of obstructive coronary artery disease (stenosis of \\> 70% of luminal diameter or \\> 50% of luminal diameter with ischemic symptoms in one or more coronary arteries), documented history of myocardial infarction or stroke.\n16. History of malignancy of any type, with the following exceptions: in situ cervical cancer more than 5 years prior to Screening or surgically excised non-melanomatous skin cancers more than 2 years prior to Screening.\n17. Positive serologic test at Screening for infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV).\n18. Participants with positive alcohol or drug screen results considered clinically significant or indicative of ongoing abuse, as judged by the Investigator.\n19. History or evidence of any other clinically significant disorder, condition, or disease (with the exception of those outlined above) that, in the opinion of the Investigator, would pose a risk to participants' safety or interfere with the study evaluation, procedures, or completion.\n20. Participated in a clinical trial where the participants received any investigational drug (or is currently using an investigational device) within 30 days prior to Screening, or at least 5 times the respective elimination half-life (whichever is longer).\n21. Current use of tobacco- or nicotine-containing products \\> 20 cigarettes\u002Fday or equivalent.\n22. Prior treatment with cardiotoxic agents such as doxorubicin or similar, or current treatment with antiarrhythmic drugs that have negative inotropic activity, eg, flecainide or propafenone.\n23. Unable to comply with the study restrictions\u002Frequirements, including the number of required visits to the clinical site.","ALL","18 Years","70 Years",{"count":20,"type":21},56,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The goal of this clinical trial is designed to characterise the safety, tolerability, efficacy, and PK of Aom0304 across oHCM and nHCM populations and to inform dose selection for future Phase 3 development. The main questions it aims to answer are:\n\n1. Which dose is safe and tolerant of Aom0304 in participants with HCM?\n2. Which dose is effective of 12 weeks of Aom0304 treatment in participants with oHCM or nHCM? Researchers will compare different doses of Aom0304 to see which works best. All participants will receive Aom0304, but at different dose levels depending on which cohort they joined.\n\nParticipants will:\n\n1. Undergo screening up to 28 days before enrollment to confirm eligibility\n2. Adjust dose every 2 weeks assessed by the Investigator according to predefined criteria at Titration Phase (Week 1 Day 1 to Week 8).\n3. Continuation of the last tolerated and effective dose; no further escalation is permitted at Maintenance Phase (Week 8 to Week 12).\n4. Study drug discontinued and follow up at Off-treatment Follow-up Period (at the end of Week 12 to Week 16).",[27,28,29],"Hypertrophic Cardiomyopathy (HCM)","Obstructive HCM (oHCM)","Non-obstructive HCM (nHCM)",[31,32,33,34],"Hypertrophic cardiomyopathy (HCM)","Aom0304","Left ventricular outflow tract gradient (LVOT-G)","Left ventricular ejection fraction (LVEF)","NOT_YET_RECRUITING","2026-06-23",{"date":38,"type":39},"2026-06-30","ACTUAL",{"date":41,"type":21},"2026-10-01",{"date":43,"type":21},"2028-04-30",{"name":45,"class":46},"Amckaus PTY LTD.","INDUSTRY",{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":4},"100640835","phase-2-a-dose-finding-study-of-amogammadex-sodium-for-reversing-vecuronium-and-rocuronium-induced-neuromuscular-blockade-100640835","NCT07595393","A Dose-Finding Study of Amogammadex Sodium for Reversing Vecuronium and Rocuronium-Induced Neuromuscular Blockade","A Multi-Centre, Open-Label, Phase II Study of Amogammadex Sodium as A Reversal Agent for Vecuronium Bromide or Rocuronium Bromide-Induced Moderate (at the Reappearance of T2) and Deep (PTC=1~2) Neuromuscular Blockade in Participants Undergoing ASA Grade 1-2 Elective Surgery","Inclusion criteria:\n\n1. Participants should be willing to participate in the clinical study; the participants should fully understand and know this study and sign an informed consent form; the participants should be willing to follow and be able to complete all study procedures.\n2. Male or female, 18 ≤ age ≤ 60.\n3. Participant with the grade of American Society of Anaesthesiologists (ASA) physical status classification 1-2.\n4. Participants who are scheduled to undergo approximately 2-hour surgery under TIVA with endotracheal intubation, and for whom vecuronium or rocuronium bromide is planned as the sole neuromuscular blocking agent.\n5. Body mass index (BMI) between 18 and 32 kg\u002Fm2 (both exclusive), and weight ≥ 50 kg for males and ≥ 45 kg for females.\n6. Willingness to use adequate contraception (abstinence is acceptable if it aligns with lifestyle) and refrain from pregnancy, impregnating a partner, or donating sperm\u002Fova from screening until 3 months after study completion. Females of nonchildbearing potential are exempt.\n\n1)For females of childbearing potential: an adequate method of contraception is defined as the use of a condom by the male partner combined with the use of a highly effective method of contraception, either be sexually inactive (abstinent) for 28 days prior to the first dose and throughout the study, or be using one of the following acceptable birth control methods:\n\n1. Intrauterine device in place for at least 3 months prior to dosing with a barrier method (condom or diaphragm) and spermicide (if available) throughout the study\n2. Double barrier methods (e.g., condom and diaphragm) with spermicide (if available) for at least 28 days prior to dosing and throughout the study\n3. Surgical sterilization of the partner (vasectomy for 6 months minimum) with a barrier method (e.g., condom or diaphragm) and spermicide (if available) throughout the study.\n4. Bilateral tubal occlusion (e.g. Essure-non-surgical sterility procedure and Bilateral tubal ligation), and\u002For a vasectomized partner with documented azoospermia 90 days after procedure, if that partner is the sole sexual partner.\n\n   2)For males: An adequate method of contraception is defined as use of a condom combined with the use of a highly effective method of contraception by the female partner of childbearing potential. Non-sterilized males with a female partner of childbearing potential must agree to use a double barrier method of birth control until five half-lives plus 90 days after the administration of the study drug.\n\n   7.Female participants must be non-pregnant (confirmed by a negative serum at screening and urine pregnancy test on Day -1), non-lactating, or be of nonchildbearing potential (females who have been postmenopausal \\[defined as 24 months of amenorrhea in the absence of other biological cause\\] or are surgically sterile \\[hysterectomy or bilateral oophorectomy or bilateral complete salpingectomy\\]).\n\nExclusion criteria:\n\n1. Known or expected difficult intubation due to anatomical deformities\n2. Known or suspected neuromuscular diseases, anatomical abnormality or neurological injury history that may affect neuromuscular transmission.\n3. History or manifestation of disease that, in the opinion of the investigator, renders the participant unsuitable for the study, including but not limited to nervous system, cardiovascular, blood, lymphatic, immune, kidney, liver, gastrointestinal, respiratory, metabolic, and musculoskeletal disorders.\n4. Participants with abnormal blood pressure not satisfactorily controlled (systolic blood pressure \\>160 mmHg or \\\u003C 90 mmHg, diastolic blood pressure \\> 100 mmHg or \\\u003C 60 mmHg). For subjects with systolic blood pressure ≥ 140 mmHg and ≤ 160 mmHg or diastolic blood pressure ≥ 90 mmHg and ≤ 100 mmHg and a history of well-controlled blood pressure, and no definite discomfort symptoms, the determination of clinical significance will be made at investigator discretion.\n5. Known heart failure or other serious cardiovascular diseases with New York Heart Association (NYHA) functional class III or IV; with abnormal ECG, QTcF interval (using Fridericia's formula) male \\> 450 ms, female \\> 470 ms, which is judged to have clinical significance by the investigators; with resting heart rate \\\u003C 60 bpm or \\> 100 bpm, which is judged to have clinical significance by the investigators.\n6. History of human immunodeficiency virus (HIV); or positive results at screening for HIV antibody\u002Fantigen (HIV Ab\u002FAg)\n7. Hepatic insufficiency or known liver disease:\n\n   1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 2.0 × upper limit of normal (ULN);\n   2. Known liver disease, such as acute hepatitis, chronic hepatitis (HBsAg positive with liver function abnormalities meeting the above criterion a, anti-HCV positive), liver cirrhosis, etc., deemed by the investigator as inappropriate for study inclusion.\n8. kidney function impairment: Serum creatinine (Cr) \\>1.5 × ULN or having previously known severe kidney diseases or Estimated Glomerular Filtration Rate (eGFR) (CKD-EPI 2021 formula) \\\u003C 60 ml\u002F(min·1.73m²) or renal insufficiency.\n9. Participants who had hereditary haemorrhagic diseases, coagulation disease, or non-traumatic bleeding history (bleeding that requires treatment), and thromboembolism; and currently have a risk of haemorrhage (including coagulation disease, thrombocytopenia \\[platelet count \\\u003C 100×109\u002FL\\], thrombin original international standardized ratio \\> 1.5 or on a routine anticoagulation therapy).\n10. Participants known or suspected to have malignant hyperthermia or with family history; febrile illness defined as a body temperature above 37.5℃ within 7 days before administration.\n11. Systemic allergic reactions caused by any known reasons, including food allergy and allergy to animals; participants known or suspected to be allergic to cyclodextrin including sugammadex, anesthetics, muscle relaxants and other drugs used in general anesthesia; participants known to be allergic to gel electrodes.\n12. Participants who have taken fusidic acid and\u002For toremifene citrate within 24 hours prior to or scheduled within 24 hours after the study drug administration. Participants receiving drugs known to affect muscle relaxants within 24 hours before or during surgery (e.g., anticonvulsants, aminoglycoside antibiotics, magnesium salts \\[Mg2+\\]) except for supplements to maintain physiological levels.\n13. Participants with suspected alcohol or drug abuse;\n14. Participation in strenuous activity (e.g., heavy lifting, strenuous running, competitive sports such as basketball, football, and singles tennis, mountain climbing, rowing machine training, etc) within 48 hours prior to dosing (Day 1).\n15. Anatomical deformities on upper extremities that cannot perform monitoring mentioned in the protocol: non-invasive blood pressure monitor, ECG, pulse oximetry, end-tidal capnography and neuromuscular monitoring.\n16. Participants who participated in other clinical trials within 3 months before the administration.\n17. Female participants who are pregnant or breastfeeding, who have a positive serum or urine pregnancy test result, or who are unable or unwilling to take contraceptive or abstinence measures approved by the investigator during the study.\n18. Participants who are considered not suitable for participating in a clinical trial by the investigator or the surgeon.","60 Years",{"count":56,"type":21},64,[24],"Background context: Amogammadex sodium has completed Phase I-III clinical studies in China for reversal of rocuronium-induced blockade. No clinical studies have yet been conducted for vecuronium-induced blockade. Therefore, this dose-finding study in an Australian population is intended to support further Phase III trials in European and American populations for reversal of both rocuronium- and vecuronium-induced neuromuscular blockade.\n\nThe goal of this clinical trial is to explore how well different doses of amogammadex sodium work to reverse neuromuscular blockade caused by rocuronium or vecuronium during surgery, and to learn about its safety. The main questions it aims to answer are:\n\n* How quickly and effectively does amogammadex sodium restore muscle strength after moderate or deep neuromuscular blockade?\n* What medical problems do participants have when receiving amogammadex sodium?\n\nResearchers will compare different doses of amogammadex sodium to see which works best. All participants will receive amogammadex sodium, but at different dose levels depending on when they join the study.\n\nParticipants will:\n\n* Undergo screening up to 28 days before surgery to confirm eligibility\n* Receive amogammadex sodium at the end of surgery to reverse the effects of the muscle relaxant\n* Stay in the study for follow-up visits up to 7 days after surgery.",[60,61],"Reversing Vecuronium-Induced Neuromuscular Blockade in Patients Undergoing General Anesthesia Surgery","Reversing Rocuronium-Induced Neuromuscular Blockade in Patients Undergoing General Anesthesia Surgery",[63,64,65,66,67],"Amogammadex sodium","neuromuscular blockade","Adamgammadex sodium","rocuronium bromide","vecuronium bromide","2026-05-12",{"date":70,"type":39},"2026-05-19",{"date":72,"type":21},"2026-08-01",{"date":74,"type":21},"2027-12-30",{"name":45,"class":46},""]