[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100239584":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":25,"locations":28,"responsibleParty":40,"collaborators":25,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":25,"eligibilityCriteria":48,"healthyVolunteers":49,"sex":50,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":25,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":25,"overallStatus":64,"whyStopped":25,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":73,"locationsCount":74},{"fullName":5,"class":6},"Zai Lab Pty. Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ZL-2102","ACTIVE_COMPARATOR","Planned to be administrated in an ascending manner: 5,20,60,150,300,500,750mg",[13],"Drug: ZL-2102",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Placebo matching ZL-2102",[19],"Drug: Placebo matching ZL-2102",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","A selective and reversible inhibitor of Hematopoietic Prostaglandin D Synthase (HPGDS).",[9],null,{"type":22,"name":17,"description":25,"armGroupLabels":27,"otherNames":25},[15],[29],{"facility":30,"status":25,"city":31,"state":25,"zip":25,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":25},"Linear Clinical Research Unit","Perth","Australia","AU",{"type":35,"coordinates":36},"Point",[37,38],115.8614,-31.95224,{"lat":38,"lon":37},{"type":41,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100239584","phase-1-study-of-the-tolerability-and-pharmacokinetic-of-zl-2102-with-an-investigation-of-food-effect-in-healthy-male-subjects-100239584",false,"NCT02397005","Study of the Tolerability and Pharmacokinetic of ZL-2102 With an Investigation of Food Effect in Healthy Male Subjects","Randomized, Double-blind, Placebo-controlled Study of the Tolerability and Pharmacokinetics of Ascending Single and 14-day Repeated Oral Doses of ZL-2102 With a Pilot Investigation of Food Effect in Healthy Male Subjects","Inclusion Criteria:\n\n* Male subject, between 18 and 45 years of age inclusive.\n* Body weight between 50.0 and 100.0 kg inclusive, body mass index (BMI) between 18.0 and 30.0 kg\u002Fm² inclusive.\n* Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).\n* Normal vital signs after 5 minutes resting in a semi recumbent position.\n* Normal standard 12-lead ECG after 5 minutes resting in a semi recumbent position.\n* Laboratory parameters within the normal range, or considered not clinically significant by the Investigator.\n* Subject returns a negative result to the Serology,Urine drug screen and alcohol breath tests.\n* Having given written informed consent prior to any procedure related to the study.\n* Not under any administrative or legal supervision.\n* Males must agree to use adequate contraception for the duration of the study and for 3 months post completion of dosing.\n* Subject agrees to the following study restrictions:\n\n  1. Subject will not consume citrus fruits and their juices for 5 days before the start of the study, and for the duration of the study.\n  2. Subject will not consume alcohol, tea, coffee, chocolate, quinine or caffeine-containing beverages from Day 1 and for the duration of the study.\n  3. Subject will note smoke or use tobacco from Day 1 and for the duration of the study.\n  4. Subject will avoid intensive physical activity from Day 1 and for the duration of the study.\n\nExclusion Criteria:\n\n* Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteo-muscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness.\n* Frequent headaches and\u002For migraine, recurrent nausea and\u002For vomiting (more than twice a month).\n* Blood donation, any volume, within 2 months prior to Screening.\n* Symptomatic postural hypotension, whatever the decrease in blood pressure, or asymptomatic postural hypotension defined by a decrease in systolic blood pressure ≥ 20 mmHg within 3 minutes when changing from the supine to the standing position.\n* Presence or history of drug hypersensitivity, or allergic disease (excluding hay fever) diagnosed and treated by a physician.\n* History or presence of drug or alcohol abuse (alcohol consumption \\>40 grams per day).\n* Smoking more than 5 cigarettes or equivalent per day, unable to stop smoking during the study.\n* Excessive consumption of beverages with xanthine bases (\\>4 cups or glasses per day).\n* Any prescription medication within 14 days and any over the counter medication within 7 days before Screening or within 5 times the elimination half-life or Pharmacodynamic half-life of that drug whichever is longest unless approved by both the Investigator and the Medical Monitor; any vaccination within the last 28 days. If necessary, paracetamol (acetaminophen) may be administered with the approval of the Investigator.\n* Any subject who, in the judgment of the Investigator, is likely to be non-compliant during the study, or unable to cooperate because of a language problem or poor mental development.\n* Receipt of any investigational study drug within 30 days prior to screening.\n* Any subject who is the Investigator or any sub-investigator, research assistant, pharmacist, study coordinator, or other staff thereof, directly involved in the conduct of the protocol.",true,"MALE","18 Years","45 Years",{"count":54,"type":55},120,"ACTUAL","INTERVENTIONAL",[58],"PHASE1","The first-in-man study are designed as below to assess safety, tolerability, and preliminary pharmacokinetics of ZL-2102.\n\n* Double-blind randomized, placebo-controlled ascending single oral doses (Part 1, ZL-2102-SAD);\n* Open-label, randomized, 2-sequence, 2-period, 2-treatment crossover (Part 2, ZL-2102-FED);\n* Double-blind randomized, placebo-controlled, ascending repeated oral doses for 14 days (Part 3, ZL-2102-MAD).\n\nA total of 104 subjects will be enrolled.",[61,62,63],"Chronic Obstructive Pulmonary Disease","Asthma","Idiopathic Pulmonary Fibrosis","UNKNOWN","2019-01-22",{"date":67,"type":55},"2019-01-24",{"date":69,"type":55},"2015-03",{"date":71,"type":72},"2019-08","ESTIMATED",{"name":5,"class":6},1]