[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603712":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":39,"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":71,"overallStatus":76,"whyStopped":26,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Biolexis Therapeutics","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"BLX-0871 Oral Dose","EXPERIMENTAL","Participants will receive oral BLX-0871 as a single dose (in Part 1 or 2) or once daily for 7 days (in Part 3).",[13],"Drug: BLX-0871",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo to match BLX-0871","PLACEBO_COMPARATOR","Participants will receive an oral placebo that looks like BLX-0871 but does not contain active drug as a single dose (in Part 1 or 2) or once daily for 7 days (in Part 3).",[19],"Drug: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","BLX-0871","BLX-0871 Single or Multiple doses administered orally as a tablet",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo","Participants will receive matching placebo of BLX-0871 for each of the oral cohorts.",[15],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Jeremiah Bearss, MD, PhD","CONTACT","(385) 476-3080","jbearss@biolexistx.com",{"name":38,"role":34,"phone":35,"phoneExt":26,"email":26},"Matthew Anthony, BS, BS",[40],{"facility":41,"status":26,"city":42,"state":43,"zip":26,"country":44,"countryCode":45,"cosmosGeoPoint":26,"geoPoint":26,"contacts":46},"Nucleus Network St Kilda Road","Melbourne","New South Wales","Australia","AU",[47],{"name":26,"role":34,"phone":48,"phoneExt":26,"email":26},"(03) 8593 9801",{"type":50,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100603712","phase-1-a-research-study-to-evaluate-blx-0871-in-healthy-adults-100603712",false,"NCT07140081","A Research Study to Evaluate BLX-0871 in Healthy Adults","A Phase 1 Randomized, Double-blind, Placebo-controlled Single-ascending Dose and Multiple-ascending Dose (SAD and MAD) Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Isoform-specific AMPK Activator BLX-0871 in Healthy Adults With a Body Mass Index (BMI) of 20 - 35 kg\u002Fm2","Inclusion Criteria:\n\n* Healthy males or females, 18-65 years, BMI 20-35 kilograms\u002Fmeter² (kg\u002Fm²), weight ≥50 kilograms (kg).\n* Normal or clinically acceptable labs, vital signs\n* HbA1c \\\u003C6.5%, non-fasting glucose 4.0-7.8 milimol\u002FLiter (mmol\u002FL)\n* Willing to follow contraception requirements, avoid alcohol, nicotine, and blood donation per protocol, and comply with all study visits and procedures.\n\nExclusion Criteria:\n\n* History of diabetes, clinically significant cardiovascular, hepatic, renal, gastrointestinal, psychiatric, or neurologic disease, or abnormal labs\u002FEchocardiograms (ECG) deemed clinically relevant.\n* Prior gastrointestinal (GI) surgery affecting absorption (e.g., gastric bypass) or chronic GI disorders.\n* History or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia type 2 (MEN2); malignancy within 5 years (except treated basal cell or in situ cervical cancer).\n* History of severe allergic reactions, seizures, or psychiatric hospitalization; positive drug, alcohol, or cotinine test.\n* Use of prescription drugs, Over the counter (OTC) \u002Fherbal supplements\n* Participation in another clinical trial or blood donation within 30 days (or 5 half-lives of prior drug).\n* Any condition or history that may compromise safety, study conduct, or compliance, in the opinion of the Investigator.",true,"ALL","18 Years","65 Years",{"count":63,"type":64},76,"ESTIMATED","INTERVENTIONAL",[67],"PHASE1","This study will test an oral medicine called BLX-0871, which is being developed to improve metabolic health by activating AMP-activated protein kinase (AMPK), a key regulator of energy balance. The main goal is to see if BLX-0871 is safe and well tolerated when given to healthy adults. The study will also measure how the body processes BLX-0871, including how quickly it is absorbed, how long it stays in the blood, and how it is eliminated. Another objective is to see whether food affects the absorption of BLX-0871. It will also look at how the drug affects the body by looking at markers of AMPK activity.",[70],"Normal Healthy Adults",[23,72,73,74,75],"0871","Obesity","Metabolic disorders","Normal health volunteer","NOT_YET_RECRUITING","2025-08-22",{"date":79,"type":80},"2025-08-24","ACTUAL",{"date":82,"type":64},"2025-09",{"date":84,"type":64},"2026-05",{"name":5,"class":6},1]