[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100299098":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":26,"locations":35,"responsibleParty":49,"collaborators":26,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":26,"eligibilityCriteria":57,"healthyVolunteers":58,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":26,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":26,"overallStatus":71,"whyStopped":26,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Viatris Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"AC-076 sc administration - single ascending dose","EXPERIMENTAL","On Day 1, 48 subjects will receive AC-076 at different single dose levels in a sequential manner and in a maximum of 6 dose levels, starting from 1 mg. Subjects will be followed by an observation period of 48 h. Each dose level will be investigated in a new group of 8 healthy male subjects (6 on active drug and 2 on placebo)",[13],"Drug: AC-076 for s.c. administration",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","For each AC-076 dose level tested, 2 healthy male subjects will receive matching placebo in the same condition",[19],"Drug: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","AC-076 for s.c. administration","Lyophilized AC-076A to be reconstituted with 1 mL of water for injection",[9],null,{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"Sterile 0.9% w\u002Fv sodium chloride solution",[15],[31],{"name":32,"affiliation":33,"role":34},"Clinical Trials","Viatris Innovation GmbH","STUDY_DIRECTOR",[36],{"facility":37,"status":26,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":26},"Biotrial Inc.","Newark","New Jersey","07103","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-74.17237,40.73566,{"lat":47,"lon":46},{"type":50,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100299098","phase-1-a-study-conducted-in-healthy-male-subjects-to-investigate-the-safety-and-tolerability-of-ac-76-its-fate-in-the-body-and-its-effect-on-the-body-100299098",false,"NCT03173625","A Study Conducted in Healthy Male Subjects to Investigate the Safety and Tolerability of AC-76, Its Fate in the Body, and Its Effect on the Body","Single-center, Double-blind, Placebo-controlled, Randomized, Single-ascending Dose Study to Investigate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamics of AC-076 in Healthy Male Subjects","Inclusion Criteria:\n\n* Signed informed consent\n* Body mass index (BMI) of 18.0 to 31.0 kg\u002Fm2 (inclusive) at screening\n* Systolic blood pressure (SBP) 100-145 mmHg, diastolic blood pressure (DBP) 50-90 mmHg, and pulse rate 45-90 beats per minute (inclusive) at screening\n* Healthy on the basis of physical examination, electrocardiogram and laboratory tests\n* Maximum (at peak) platelet aggregation ≥ 40%\n* Values of closure time tested with the Platelet Function Analyzer (PFA) equipment, for both cartridges of collagen\u002Fepinephrine and collagen\u002FADP below the upper limit of normal range at screening\n\nExclusion Criteria:\n\n* Known hypersensitivity to AC-076 or drugs of the same class, or any of their excipients\n* Family or personal history of prolonged bleeding or bleeding disorders, intracranial vascular diseases, stroke, reasonable suspicion of vascular malformations, or peptic ulcers\n* Platelet count \\\u003C 120 × 109 L-1 at screening\n* Known platelet disorders\n* Orthostatic hypotension at screening (i.e., decrease from supine to standing BP of \\> 20 mmHg in SBP or \\> 10 mmHg in DBP after being in standing position for 3 min)\n* Previous treatment with acetylsalicylate, non-steroidal anti-inflammatory drugs or any medication with blood thinning activity within 3 weeks prior to study drug administration; or with any other prescribed medications (including vaccines) or over the counter medications within 2 weeks prior to study drug administration\n* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol",true,"MALE","18 Years","45 Years",{"count":63,"type":64},72,"ACTUAL","INTERVENTIONAL",[67],"PHASE1","The main objective of the study is to investigate the safety and tolerability of single ascending doses of AC-076 administered as subcutaneous injection",[70],"Healthy Subjects","COMPLETED","2025-07-01",{"date":74,"type":64},"2025-07-02",{"date":76,"type":64},"2016-11-29",{"date":78,"type":64},"2017-04-15",{"name":33,"class":6},1]