[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"healthy-male-adults-participants\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:healthy-male-adults-participants":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100637125","phase-1-a-study-to-evaluate-the-pk-similarity-of-ak104-in-healthy-chinese-male-participations-100637125",false,"NCT07619001","A Study to Evaluate the PK Similarity of AK104 in Healthy Chinese Male Participations","A Phase I Study to Evaluate the PK Similarity of AK104 (Anti-PD-1\u002FCTLA-4 Bispecific Antibody) From the Proposed New Manufacturing Site and the Approved Original Site in Chinese Healthy Male Participants.","Inclusion Criteria:\n\n1. Able to provide signed informed consent prior to the trial and fully understand the trial content, procedures, and potential adverse reactions.\n2. Able to complete the study as required by the trial protocol.\n3. Males aged 18 to 45 years.\n4. Body Mass Index (BMI) is 19.0 \\~ 26.0 kg\u002Fm² and body weight is 55.0 \\~ 75.0 kg.\n5. Non-sterilized male participants must agree to remain completely abstinent or use a barrier contraceptive method (male condom) during the study period and for 6 months after the completion of the investigational drug infusion, and must refrain from sperm donation. Their female partners must agree to use at least one highly effective contraceptive method (e.g., sterilization surgery, contraceptive pills, injectable contraceptive medroxyprogesterone, or subdermal implant) during the study period and for 6 months after the completion of the investigational drug infusion.\n\nExclusion Criteria:\n\n1. Have a history of diseases of the digestive, respiratory, cardiovascular, endocrine, urinary, nervous, or hematologic systems, or metabolic disorders, which, in the investigator's opinion, is still clinically significant at the time of screening.\n2. Have a history of malignancy (excluding successfully resected cutaneous squamous cell carcinoma, basal cell carcinoma, or localized cervical carcinoma in situ with no evidence of metastasis).\n3. Have a history of autoimmune disease (including personal or family history of hereditary immunodeficiency).\n4. Have a history of tuberculosis or clinical manifestations suggestive of tuberculosis (including but not limited to pulmonary tuberculosis, lymph node tuberculosis, tuberculous pleurisy, etc.).\n5. Have a history of recurrent or chronic infection, or chronic or recurrent infections including but not limited to: chronic renal infection, chronic chest infection (e.g., bronchiectasis), sinusitis, recurrent urinary tract infection, open, draining, or infected skin wounds.\n6. Have a history of acute infection within 2 weeks prior to randomization, or opportunistic infection within 6 months prior to randomization (e.g., herpes zoster, active cytomegalovirus, Pneumocystis jirovecii, Histoplasma, Aspergillus, Mycobacterium, etc.).\n7. Undergone major surgery or sustained severe trauma within 3 months prior to randomization, or plan to undergo surgery during the study period.\n8. Donated blood or experienced significant blood loss (≥400 mL), received a blood transfusion or used blood products within 3 months prior to randomization, or plan to donate blood or blood components during the study period or within 3 months after the end of the study.\n9. Have a known allergy to any component of the investigational drug, or a history of allergy to drugs, foods, or other substances.\n10. Have difficulty with venous blood collection (e.g., unable to tolerate venipuncture, history of needle or blood phobia, poor venous access, etc.).\n11. Have electrocardiogram abnormalities (e.g., QTcF \\> 450 ms, shortened or prolonged PR interval, second- or third-degree atrioventricular block, Wolff-Parkinson-White syndrome, etc.) that are considered clinically significant by the investigator.\n12. Urine drug screen test positive (for morphine, methamphetamine, ketamine, methylenedioxymethamphetamine, tetrahydrocannabinolic acid).\n13. Alcohol breath test result \\> 0 mg\u002F100 mL.\n14. Have a history of hepatitis B, hepatitis C, HIV, or syphilis, or have positive diagnostic test results for hepatitis B, hepatitis C, HIV, or syphilis.\n15. Have abnormalities in other examinations (physical examination, vital signs, chest X-ray, laboratory tests, etc.) that are considered clinically significant by the investigator.\n16. Previously received any agent targeting PD-1\u002FPD-L1 or CTLA-4.\n17. Received any other investigational drug or participated in another interventional clinical trial within 3 months prior to screening.\n18. Used any medication (including traditional Chinese herbs, health supplements, etc.) within 14 days prior to randomization, or within a period shorter than 5 half-lives of the last medication before the investigational drug administration day, whichever is longer.\n19. Received a live or live-attenuated vaccine within 3 months prior to randomization, or an inactivated vaccine within 14 days prior to randomization, or plan to receive vaccination during the study period.\n20. Have a history of drug abuse or use of soft drugs (e.g., cannabis) or hard drugs (e.g., cocaine, phencyclidine, etc.) within 1 year prior to randomization.\n21. Heavy smokers or have smoked ≥5 cigarettes per day on average within 3 months prior to randomization, or are unwilling to stop using any tobacco products during hospitalization.\n22. Alcoholics or have a history of regular alcohol consumption within 6 months prior to randomization, i.e., consuming more than 14 units of alcohol per week (1 unit = 360 mL of beer, 45 mL of spirit with 40% alcohol content, or 150 mL of wine); or are unwilling to stop alcohol consumption or any alcohol-containing products during the study period.\n23. Consume excessive amounts of tea, coffee, and\u002For caffeinated beverages on average per day (\\>8 cups, 1 cup = 250 mL), or do not agree to refrain from consuming tea, coffee, and\u002For caffeinated foods, grapefruit (pomelo) and\u002For grapefruit juice, and\u002For products containing poppy during the study period.\n24. Have special dietary requirements (e.g., vegetarian), are unable to comply with a standardized diet, or have lactose intolerance.\n25. Unable to complete this study or follow the study procedures for any other reason, or are considered by the investigator to have any other condition that makes them unsuitable for participation in this study.",true,"MALE","18 Years","45 Years",{"count":21,"type":22},158,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This study is to evaluate the pharmacokinetic (PK) similarity of AK104 (an anti-PD-1\u002FCTLA-4 bispecific antibody) from the proposed new manufacturing site and the approved original site in healthy male participants.",[28],"Healthy Male Adults Participants",[30],"AK104","NOT_YET_RECRUITING","2026-05-26",{"date":34,"type":35},"2026-06-01","ACTUAL",{"date":34,"type":22},{"date":38,"type":22},"2026-12-30",{"name":40,"class":41},"Akeso","INDUSTRY",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":16,"sex":17,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":4},"100564026","alternative-protein-satiety-study-apes-study-100564026","NCT06623812","Alternative ProtEin Satiety Study (APES Study)","Satiety Responses of Meals Consisting of Different Protein Sources","APES","Inclusion Criteria:\n\n* Healthy male\n* Aged between 21 and 50-year-old\n* Are of normal weight (BMI 18-25kg\u002Fm2)\n* Stable weight for the previous 12 months (\\<5kg weight fluctuation in the previous year)\n* Healthy dentition and ability to bite, chew and swallow normally\n* No history of pain or discomfort in jaw movements or excessive teeth clenching or grinding\n* No dental carries or periodontal disease\n* Own a mobile device with Apple iOS Operating System version 15.0 -17.3 or Android Operating System version 10-14\n* Have access to a data plan\n* Comfortable with needles and insertion of a Continuous Glucose Monitoring System device for 3-7 days\n\nExclusion Criteria:\n\n* Are a smoker\n* Have any dislikes, intolerances or allergies to foods or common food ingredients e.g. nuts, soya, wheat, gluten, cereal, fruits, biscuits, dairy products, rice, vegetable, meat, seafood, sugar and sweetener, gelatin, natural food colourings or flavourings (e.g. MSG), etc.\n* Have any specific dietary requirements and\u002F or restrictions (e.g. Vegan\u002F vegetarian, religious beliefs, lactose intolerance, calorie restricted diet etc.)\n* Known sensitivity to medical-grade adhesives\n* Bleeding disorders (e.g Hemophilia, von Willebrand disease etc.)\n* Have sinus problems that affect your taste and smell\n* Have known glucose-6-phosphate dehydrogenase (G6PD) deficiency\n* Are taking insulin or medication known to affect your appetite or metabolism\n* Have major chronic diseases such as heart disease, cancer or diabetes mellitus etc.\n* Have active Tuberculosis (TB) or currently receiving treatment for TB\n* Have any known Chronic Infection or known to suffer from or have previously suffered from or is a carrier of Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV)\n* Are a member of the research team or their immediate family members. Immediate family member is defined as a spouse, parent, child, or sibling, whether biological or legally adopted\n* Are enrolled in a concurrent research study judged not to be scientifically or medically compatible with this study","21 Years","50 Years",{"count":54,"type":22},50,[56],"NA","This project aims to study the effects of different protein quality (i.e. high vs. low) and protein sources (i.e. plant protein vs. conventional animal protein) on post-meal satiety and satisfaction. The protein quality score of meals will be calculated using the published digestible indispensable amino acid score (DIAAS). The proposed study will investigate the link between protein quality, protein source, and the post-meal satiety responses, using a realistic lunch meal approach, in humans. Other than the self-reported visual analogue scale (VAS) satiety response, the postprandial glucose dips (i.e. 2-3hours post-meal) will be collected by continuous glucose monitoring (CGMS) as an objective indicator of postprandial self-reported hunger and subsequent energy intake. In addition, the oral processing behaviours of participants will be captured and compared between the test meals.",[28],[60,61,62],"Satiety","Alternative Protein","Protein Quality","2024-09-30",{"date":65,"type":35},"2024-10-02",{"date":67,"type":22},"2024-10",{"date":69,"type":22},"2024-12",{"name":71,"class":72},"Singapore Institute of Food and Biotechnology Innovation","OTHER_GOV"]