[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Prospect Therapeutics (Nanjing) Limited\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":66},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"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":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100650893","phase-1-pstc100-study-in-healthy-adult-subjects-100650893",false,"NCT07752472","PSTC100 Study in Healthy Adult Subjects","A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PSTC100 in Healthy Adult Subjects","Inclusion Criteria:\n\n* 1.Fully understand the purpose and process of this study, voluntarily participate, and sign an informed consent form;\n* 2.At the time of screening, applicants must be between 18 and 55 years old (inclusive), and there are no gender restrictions.\n* 3.Body mass index (BMI) is between 18.0 and 32.0 kg\u002Fm² (inclusive).\n* 4.Male participants should weigh no less than 50 kg, and female participants should weigh no less than 45 kg.\n* 5.Based on the medical history, vital signs, physical examination, 12-lead electrocardiogram, laboratory tests (hematology, blood biochemistry, coagulation function, urinalysis), and other examination results, the subjects were in good health and no clinically significant abnormalities were found.\n* 6.Female subject has no plans to conceive from the start of the screening period until 40 days after the last dose, and agrees to use contraceptive methods as detailed further in the protocol (see Appendix 11.2) from the time of signing the informed consent form until 40 days after the last dose. Male subject agrees to use contraceptive methods as detailed further in the protocol (see Appendix 11.2) with partners of childbearing potential from the time of signing the informed consent form until 100 days after the last dose.\n* 7.Male subjects must agree to refrain from sperm donation from the time of signing the informed consent form until 100 days after the last dose and female subjects must refrain from ova donation from the time of signing the informed consent form until 40 days after the last dose.\n\nExclusion Criteria:\n\n* 1.Pregnant women (or those with a positive pregnancy test), or breastfeeding women;\n* 2.During the screening and baseline period, the pulse rate ≤ 45 beats\u002Fminute or \\> 100 beats\u002Fminute;\n* 3.During the screening and baseline period, systolic blood pressure \\\u003C90 mmHg or ≥140 mmHg, or diastolic blood pressure \\\u003C50 mmHg or ≥90 mmHg;\n* 4.Those who have special dietary requirements and cannot accept the standardized meals provided by the research center;\n* 5.Drinking alcohol or consuming beverages rich in fructose (including but not limited to carbonated soft drinks, 100% fruit\u002Fpure juice etc.) or energy drinks during the screening and baseline period may affect blood glucose, lipid profile, or muscle metabolism.\n* 6.During the screening and baseline period, drinking coffee, consuming St. John's wort, grapefruit, pomelo, cranberry, or engaging in strenuous exercise may affect drug absorption and metabolism.\n* 7.A history of eczema, no use of steroid creams for 3 months prior to screening; history fully resolved gestational diabetes; current or history of attention deficit hyperactivity disorder (ADHD), anxiety or depression (no use of antidepressants for at least 6 months prior to screening); Gilberts syndrome; or who have a history of or currently suffer from clinically confirmed cardiovascular, respiratory, digestive, endocrine, metabolic, neurological, dermatological, ophthalmic, infectious, or mental illnesses or abnormalities as per investigator's discretion;\n* 8.Suspected or confirmed allergy to any component of the investigational drug, or a confirmed history of severe allergy;\n* 9.Previous surgeries that may affect the results of clinical trials (such as cholecystectomy, partial gastrectomy, etc., but subjects with minor surgeries such as removal of superficial lipomas and appendectomy are acceptable).\n* 10.Have taken any prescription medications within 14 days prior to screening, or over-the-counter drugs and herbal remedies (except for vitamins and calcium supplements) within 7 days prior to screening. However, use of paracetamol \\\u003C 2 g per day for less than 7 days is allowed.\n* 11.Those who have lost or donated more than 400 mL of blood within the 1 month prior to screening (excluding physiological blood loss);\n* 12.Those who have participated in any clinical trials within the 3 months prior to screening (excluding those who failed the screening);\n* 13.Those with a history of alcohol abuse: those who have consumed more than 14 standard alcohol units per week in the past 1 year (1 standard alcohol unit is approximately equivalent to 250 mL of 5% ABV beer; or 100 mL of 12.5% ABV wine; or 30 mL of 42% ABV spirits); or those who do not agree to abstain from alcohol during the trial period;\n* 14.Those with a history of smoking: averaging ≥5 cigarettes per day in the 3 months prior to screening; or those who do not agree to abstain from smoking during the trial period;\n* 15.Those with a history of drug abuse (if a participant engaged in use 3 years ago and is no longer a user, he\u002Fshe is permitted to be included) or who tested positive for urine drugs abuse test during the screening and baseline period;\n* 16.During the screening and baseline period, the breathalyzer test result was \\>0 mg\u002F100mL;\n* 17.During screening, subjects with clinically significant abnormalities in any of the following: Hepatitis B surface antigen, syphilis-specific antibodies, hepatitis C antibodies, or HIV antigen\u002Fantibody.\n* 18.Any situation that researchers believe poses a safety risk to the subjects or may interfere with the conduct of this study, or any situation that researchers believe the subjects cannot comply with the relevant requirements of this study.",true,"ALL","18 Years","55 Years",{"count":21,"type":22},70,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This study is a single-center, randomized, double-blind, placebo-controlled, dose-escalation phase I clinical trial designed to evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic (PD) characteristics of PSTC100 in healthy adult subjects.",[28],"Healthy Adult Subjects",[30,31,32],"Phase 1","PSTC100","healthy adult subjects","RECRUITING","2026-09-01",{"date":36,"type":37},"2026-09-04","ACTUAL",{"date":34,"type":37},{"date":40,"type":22},"2027-10-10",{"name":42,"class":43},"Prospect Therapeutics (Nanjing) Limited","INDUSTRY",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":54,"briefSummary":55,"conditions":56,"keywords":57,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":60,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":44},"100645624","phase-1-pstb100-study-in-healthy-adult-subjects-100645624","NCT07702279","PSTB100 Study in Healthy Adult Subjects","A Phase I Clinical Study of Safety, Tolerability, and Pharmacokinetics \u002F Pharmacodynamics of Single and Multiple Ascending Doses of PSTB100 Tablets in Healthy Adult Subjects","Inclusion Criteria:\n\n* 1.Healthy subjects aged 18-55 years (inclusive) at screening, with no gender restriction.\n\nCohort 8 will enroll only male subjects aged 18-45 years (inclusive) at screening.\n\n* 2.Body Mass Index (BMI) of 18.0 to 32.0 kg\u002Fm² (inclusive), and 19.0 to 26.0 kg\u002Fm² (inclusive) for Cohort 8.\n* 3.Good health status confirmed by medical history, vital signs, physical examination, 12-lead ECG, laboratory tests (blood routine, biochemistry, coagulation function, urinalysis), etc., with no clinically significant abnormalities.\n* 4.Fully informed about the study, voluntary participation, and signed Informed Consent Form (ICF).\n* 5\\. Women of childbearing potential who have no pregnancy plan from the screening period until 1 month after the end of the trial, and agree to use contraceptive methods as detailed further in the protocol (see Appendix 3) from signing the ICF until 30 days after last dose.\n* 6.Males who agree to use contraception as detailed further in the protocol (see Appendix 3) with partners of childbearing potential from signing ICF until 90 days after last dose.\n\nExclusion Criteria:\n\n* 1.Females who are pregnant (positive or clinically abnormal pregnancy test result), lactating, or planning to become pregnant.\n* 2.Pulse rate ≤50 beats\u002Fmin or \\>100 beats\u002Fmin at screening.\n* 3.Systolic blood pressure \\\u003C90 mmHg or ≥140 mmHg, or diastolic blood pressure \\\u003C60 mmHg or ≥90 mmHg at screening.\n* 4.History or current presence of clinically significant diseases or abnormalities in cardiovascular, respiratory, digestive, endocrine, metabolic, neurological, dermatological, ophthalmological, infectious, or psychiatric systems, including but not limited to history of eczema, no use of steroid creams for 3 months prior to screening; current or history of attention deficit hyperactivity disorder (ADHD), anxiety or depression (no use of antidepressants for at least 6 months prior to screening); Gilberts syndrome.\n\nSubjects with previous non-severe diseases or cured acute diseases may be enrolled if the assessor confirms no impact on the clinical trial.\n\n* 5.Use of tobacco, coffee, St. John's wort, grapefruit, grapefruit juice, cranberry juice, or strenuous exercise within 24 hours before enrollment.\n* 6.6.Suspected or confirmed allergy to any ingredient of the investigational product, or any known allergy history (however, subjects with mild allergies such as to pollen, cats or dust, which is fully resolved or without any treatment for more than 3 years can be enrolled).\n* 7.Previous surgery that may affect the clinical trial results (including but not limited to cholecystectomy, subtotal gastrectomy; excluding minor surgeries such as subcutaneous lipoma resection).\n\n  8.Use of any medication within 14 days before the study drug administration, including over-the-counter drugs and herbal medicines (except vitamins and calcium tablets), or dietary supplement within 7 days before the study drug administration.\n* 9.Blood loss or blood donation exceeding 400 mL within 30 days before screening (physiological blood loss excluded).\n* 10.Participation in any clinical trial of investigational drugs or medical devices within 3 months (or within 5 half-lives of investigational drugs, whichever is longer) before screening (excluding subjects who failed screening).\n* 11.History of alcohol abuse. Subjects who consumed more than 14 standard alcohol units weekly within the past year (1 standard unit ≈ 250 mL of 5% beer; 100 mL of 12.5% wine; 30 mL of 42% spirits) or who refuse to abstain from alcohol during the trial.\n* 12.History of smoking abuse (average ≥ 5 cigarettes daily within 1 month before screening) or refusal to abstain from smoking during the trial.\n* 13.History of drug abuse or positive urine drug screening result during screening (subjects with positive cotinine at screening \\[D-28\\~D-2\\] will be not excluded if a negative cotinine is obtained on D-1).\n* 14.Breath alcohol test with positive result at screening.\n* 15.Clinically abnormal results of HBsAg, anti-HBcAb, anti-TP (if applicable), anti-HCV, anti-HIV, or QuantiFERON Gold.\n* 16.History of severe\u002Fserious bacterial infection, recurrent (\\>3× per year) bacterial infections, or herpes simplex virus (HSV) infection.\n* 17.Subjects who received live vaccine within 4 weeks of screening, or plan to receive live vaccine during and up to 4 weeks after the last dose of investigational product.\n* 18.Subjects for Cohort 8 will be excluded if:\n\n  * Experienced cold, infection, etc., within 4 weeks before screening.\n  * Have contraindications or are unsuitable for lumbar puncture.\n* 19\\. Any other situation that the researcher considers may bring safety risks to the subject, interfere with the study, or that the subject may not complete the study or comply with the requirements (due to management reasons, dysphagia, or other reasons).",{"count":53,"type":22},68,[25],"This study is a randomized, double-blind, placebo-controlled, dose-escalation， first-in-human clinical trial in healthy adults, designed to assess the safety, tolerability, and PK characteristics of PSTB100 tablets.",[28],[58,59,32],"Phase I","PSTB100",{"date":36,"type":37},{"date":62,"type":37},"2026-07-14",{"date":64,"type":22},"2027-09-06",{"name":42,"class":43},""]