[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657817":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":40,"studyPopulation":11,"armGroups":41,"interventions":54,"overallOfficials":62,"centralContacts":67,"locations":73,"responsibleParty":85,"collaborators":11,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":11,"eligibilityCriteria":93,"healthyVolunteers":94,"sex":95,"minAge":96,"maxAge":97,"enrollmentInfo":98,"targetDuration":11,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":11,"overallStatus":107,"whyStopped":11,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Tangram Therapeutics Plc","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Frequency and severity of adverse events [Safety and tolerability]",null,"From start of study drug administration through 16 weeks after study drug administration.",[14,18,22,25,28],{"measure":15,"description":16,"timeFrame":17},"Area under the plasma concentration-time curve (AUC) of TGM-148 (ng·h\u002FmL)","Area under the plasma concentration-time curve derived from plasma concentration-time data.","From start of study drug administration through 48 hours after the last study drug administration.",{"measure":19,"description":20,"timeFrame":21},"Maximum observed plasma concentration (Cmax) of TGM-148 (ng\u002FmL)","Maximum observed plasma concentration derived from plasma concentration-time data.","From start of study drug administration through 48 hours after study drug administration.",{"measure":23,"description":24,"timeFrame":21},"Time of maximum plasma concentration (Tmax) of TGM-148","Time of maximum observed plasma concentration derived from plasma concentration-time data.",{"measure":26,"description":27,"timeFrame":21},"Half life (T½) of TGM-148","Half life derived from plasma concentration-time data.",{"measure":29,"description":30,"timeFrame":12},"Change from baseline in target biomarker levels in plasma","Change from baseline in target biomarker levels in plasma samples following administration of TGM-148, expressed as concentration or relative change from baseline.",{"allocation":32,"interventionModel":33,"interventionModelDescription":11,"primaryPurpose":34,"observationalModel":11,"timePerspective":11,"maskingInfo":35},"RANDOMIZED","PARALLEL","BASIC_SCIENCE",{"masking":36,"maskingDescription":11,"whoMasked":37},"DOUBLE",[38,39],"PARTICIPANT","INVESTIGATOR","This trial is a Phase 1, FIH, randomised, double-masked (sponsor unmasked), placebo-controlled, parallel-group, single ascending dose trial designed to evaluate the safety, tolerability, PK, and PD of a single SC dose of TGM-148 in healthy participants.",[42,48],{"label":43,"type":44,"description":45,"interventionNames":46},"TGM-148","EXPERIMENTAL","Participants will receive study treatment according to the assigned intervention.",[47],"Drug: TGM-148",{"label":49,"type":50,"description":51,"interventionNames":52},"Placebo","PLACEBO_COMPARATOR","Participants will receive placebo according to the assigned intervention.",[53],"Drug: Placebo",[55,59],{"type":56,"name":43,"description":57,"armGroupLabels":58,"otherNames":11},"DRUG","TGM-148 is an investigational medicinal product administered by subcutaneous injection according to a protocol-defined regimen.",[43],{"type":56,"name":49,"description":60,"armGroupLabels":61,"otherNames":11},"Placebo administered by subcutaneous injection according to a protocol-defined regimen.",[49],[63],{"name":64,"affiliation":65,"role":66},"Sponsor Medical Representative","Tangram Therapeutics","STUDY_DIRECTOR",[68],{"name":69,"role":70,"phone":71,"phoneExt":11,"email":72},"Sponsor Clinical Trials Office","CONTACT","+44 20 4558 3826","clinicaltrials@tangramtx.com",[74],{"facility":75,"status":11,"city":76,"state":11,"zip":11,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":11},"Hammersmith Medicines Research","London","United Kingdom","UK",{"type":80,"coordinates":81},"Point",[82,83],-0.12574,51.50853,{"lat":83,"lon":82},{"type":86,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100657817","phase-1-safety-tolerability-pk-and-pd-of-tgm-148-in-healthy-participants-100657817",false,"NCT07843368","Safety, Tolerability, PK, and PD of TGM-148 in Healthy Participants","A First-in-human, Randomised, Double-masked (Sponsor Unmasked), Placebo-controlled, Parallel Group, Single Ascending Dose Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Subcutaneous Dose of TGM-148 in Healthy Participants","Inclusion Criteria:\n\n* Healthy adults aged 18 to 45 years who are able to provide written informed consent.\n* Medically suitable for study participation based on protocol-defined assessments.\n* Body mass index (BMI) between 18.0-30.0 kg\u002Fm² (inclusive) and a body weight \\>50 kg.\n\nExclusion Criteria:\n\n* Clinically significant medical conditions, laboratory abnormalities, or other findings that, in the opinion of the investigator, could increase risk, interfere with study participation, or confound interpretation of study results.\n* Recent participation in another investigational study.\n* Use of medications that are prohibited by the protocol.\n* Any other condition that would make the individual unsuitable for study participation as determined by the investigator.",true,"ALL","18 Years","45 Years",{"count":99,"type":100},40,"ESTIMATED","INTERVENTIONAL",[103],"PHASE1","The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) effects of single ascending doses of TGM-148 in healthy adults",[106],"Healthy Participants","NOT_YET_RECRUITING","2026-09-21",{"date":110,"type":111},"2026-09-28","ACTUAL",{"date":113,"type":100},"2026-10",{"date":115,"type":100},"2028-03",{"name":5,"class":6},1]