[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100053332":3},{"organization":4,"outcomesModule":7,"designInfo":55,"detailedDescription":61,"studyPopulation":11,"armGroups":62,"interventions":81,"overallOfficials":93,"centralContacts":98,"locations":104,"responsibleParty":396,"collaborators":11,"id":398,"slug":399,"hasResults":400,"nctId":401,"briefTitle":402,"officialTitle":403,"acronym":11,"eligibilityCriteria":404,"healthyVolunteers":400,"sex":405,"minAge":406,"maxAge":407,"enrollmentInfo":408,"targetDuration":11,"studyType":411,"phases":412,"briefSummary":414,"conditions":415,"keywords":11,"overallStatus":107,"whyStopped":11,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":418,"startDateStruct":421,"completionDateStruct":423,"leadSponsor":425,"locationsCount":426},{"fullName":5,"class":6},"Tyra Biosciences, Inc","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":11},[9,13],{"measure":10,"description":11,"timeFrame":12},"Incidence of treatment-related adverse events as assessed by CTCAE v5.0",null,"Up to 12 months",{"measure":14,"description":11,"timeFrame":15},"Change from baseline in annualized growth velocity (Cohort 1)","12 months",[17,19,22,25,27,29,31,33,35,37,39,41,43,45,47,49,51,53],{"measure":14,"description":11,"timeFrame":18},"6 months",{"measure":20,"description":11,"timeFrame":21},"Change from baseline in height z-score (Cohort 1)","6 and 12 months",{"measure":23,"description":11,"timeFrame":24},"Pharmacokinetics: maximum plasma concentration (Cmax)","15 days",{"measure":26,"description":11,"timeFrame":24},"Pharmacokinetics: time to reach maximum plasma concentration (Tmax)",{"measure":28,"description":11,"timeFrame":24},"Pharmacokinetics: area under the plasma concentration-time curve (AUC)",{"measure":30,"description":11,"timeFrame":24},"Pharmacokinetics: half-life of TYRA-300 (t1\u002F2)",{"measure":32,"description":11,"timeFrame":24},"Pharmacokinetics: apparent total clearance (CL\u002FF)",{"measure":34,"description":11,"timeFrame":24},"Pharmacokinetics: apparent volume of distribution (Vd\u002FF)",{"measure":36,"description":11,"timeFrame":21},"Change from baseline in annualized growth velocity (Cohort 2)",{"measure":38,"description":11,"timeFrame":21},"Change from baseline in height z-score (Cohort 2)",{"measure":40,"description":11,"timeFrame":21},"Change from baseline in standing height (cm)",{"measure":42,"description":11,"timeFrame":21},"Change from baseline in sitting height (cm)",{"measure":44,"description":11,"timeFrame":21},"Change from baseline in upper and lower arm length (cm)",{"measure":46,"description":11,"timeFrame":21},"Change from baseline in tibial length (cm)",{"measure":48,"description":11,"timeFrame":21},"Change from baseline in femur length (cm)",{"measure":50,"description":11,"timeFrame":21},"Change from baseline in arm span proportionality (arm span\u002Fheight ratio)",{"measure":52,"description":11,"timeFrame":21},"Change from baseline in upper segment\u002Flower segment ratio",{"measure":54,"description":11,"timeFrame":21},"Change from baseline in elbow extension",{"allocation":56,"interventionModel":57,"interventionModelDescription":11,"primaryPurpose":58,"observationalModel":11,"timePerspective":11,"maskingInfo":59},"NON_RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":60,"maskingDescription":11,"whoMasked":11},"NONE","This is a Phase 2, multicenter, open-label, dose-escalation study to determine the safety, tolerability, and identify potentially effective dose(s) of TYRA-300, a fibroblast growth factor receptor (FGFR)-3 selective tyrosine kinase inhibitor, in children 3 to 10 years of age with achondroplasia with open growth plates that will examine three cohorts of children: the Sentinel Safety Cohort, Cohort 1, and Cohort 2.",[63,69,73,77],{"label":64,"type":65,"description":66,"interventionNames":67},"TYRA-300 0.125 mg\u002Fkg","EXPERIMENTAL","TYRA-300 is provided as sprinkle capsules\u002Fmini-tablets. The total dose will be calculated based on the participant's weight. Weight adjustments will be made every 3 months.",[68],"Drug: TYRA-300 0.125 mg\u002Fkg",{"label":70,"type":65,"description":66,"interventionNames":71},"TYRA-300 0.25 mg\u002Fkg",[72],"Drug: TYRA-300 0.25 mg\u002Fkg",{"label":74,"type":65,"description":66,"interventionNames":75},"TYRA-300 0.375 mg\u002Fkg",[76],"Drug: TYRA-300 0.375 mg\u002Fkg",{"label":78,"type":65,"description":66,"interventionNames":79},"TYRA-300 0.50 mg\u002Fkg",[80],"Drug: TYRA-300 0.50 mg\u002Fkg",[82,86,89,91],{"type":83,"name":64,"description":84,"armGroupLabels":85,"otherNames":11},"DRUG","Initial dose level of TYRA-300 per protocol, subsequent dose level escalations will occur based on criteria outlined in the protocol.",[64],{"type":83,"name":70,"description":87,"armGroupLabels":88,"otherNames":11},"Subsequent dose level escalations will occur based on criteria outlined in the protocol.",[70],{"type":83,"name":74,"description":87,"armGroupLabels":90,"otherNames":11},[74],{"type":83,"name":78,"description":87,"armGroupLabels":92,"otherNames":11},[78],[94],{"name":95,"affiliation":96,"role":97},"Doug Warner, MD","Tyra Biosciences","STUDY_CHAIR",[99],{"name":100,"role":101,"phone":102,"phoneExt":11,"email":103},"Suzanne Lopez","CONTACT","(619) 728-4805","ACH@tyra.bio",[105,124,139,154,169,183,198,212,227,242,257,271,286,303,317,334,349,364,381],{"facility":106,"status":107,"city":108,"state":109,"zip":110,"country":111,"countryCode":112,"cosmosGeoPoint":113,"geoPoint":118,"contacts":119},"Lundquist Institute for Biomedical Innovation","RECRUITING","Torrance","California","90502","United States","US",{"type":114,"coordinates":115},"Point",[116,117],-118.34063,33.83585,{"lat":117,"lon":116},[120],{"name":121,"role":101,"phone":122,"phoneExt":11,"email":123},"Adolfo Morales Garval","(310) 222-3472","adolfo.morales@lundquist.org",{"facility":125,"status":107,"city":126,"state":127,"zip":128,"country":111,"countryCode":112,"cosmosGeoPoint":129,"geoPoint":133,"contacts":134},"Children's Hospital Colorado","Aurora","Colorado","80045",{"type":114,"coordinates":130},[131,132],-104.83192,39.72943,{"lat":132,"lon":131},[135],{"name":136,"role":101,"phone":137,"phoneExt":11,"email":138},"Lauren Samz","720-777-1975","Lauren.Samz@childrenscolorado.org",{"facility":140,"status":107,"city":141,"state":142,"zip":143,"country":111,"countryCode":112,"cosmosGeoPoint":144,"geoPoint":148,"contacts":149},"Nemours Alfred I duPont Hospital for Children","Wilmington","Delaware","19803",{"type":114,"coordinates":145},[146,147],-75.54659,39.74595,{"lat":147,"lon":146},[150],{"name":151,"role":101,"phone":152,"phoneExt":11,"email":153},"Judith Feinson","(302) 651-5928","judith.feinson@nemours.org",{"facility":155,"status":107,"city":156,"state":157,"zip":158,"country":111,"countryCode":112,"cosmosGeoPoint":159,"geoPoint":163,"contacts":164},"Johns Hopkins University School of Medicine","Baltimore","Maryland","21205",{"type":114,"coordinates":160},[161,162],-76.61219,39.29038,{"lat":162,"lon":161},[165],{"name":166,"role":101,"phone":167,"phoneExt":11,"email":168},"Plamena Simeonova, MD","410-614-0977","psimeon1@jh.edu",{"facility":170,"status":107,"city":171,"state":157,"zip":172,"country":111,"countryCode":112,"cosmosGeoPoint":173,"geoPoint":177,"contacts":178},"Uncommon Cures","Chevy Chase","20815",{"type":114,"coordinates":174},[175,176],-77.07115,39.00287,{"lat":176,"lon":175},[179],{"name":180,"role":101,"phone":181,"phoneExt":11,"email":182},"Tamanna Roshan Lal","240 858 4938","troshanlal@uncommoncures.com",{"facility":184,"status":107,"city":185,"state":186,"zip":187,"country":111,"countryCode":112,"cosmosGeoPoint":188,"geoPoint":192,"contacts":193},"University of Missouri","Columbia","Missouri","65201",{"type":114,"coordinates":189},[190,191],-92.33407,38.95171,{"lat":191,"lon":190},[194],{"name":195,"role":101,"phone":196,"phoneExt":11,"email":197},"Taylor Matthews","573-882-4758","mathewsta@health.missouri.edu",{"facility":199,"status":107,"city":200,"state":186,"zip":201,"country":111,"countryCode":112,"cosmosGeoPoint":202,"geoPoint":206,"contacts":207},"Washington University","St Louis","63130",{"type":114,"coordinates":203},[204,205],-90.19789,38.62727,{"lat":205,"lon":204},[208],{"name":209,"role":101,"phone":210,"phoneExt":11,"email":211},"Michelle Ritter","(314) 362-7306","michelle.ritter@wustl.edu",{"facility":213,"status":107,"city":214,"state":215,"zip":216,"country":111,"countryCode":112,"cosmosGeoPoint":217,"geoPoint":221,"contacts":222},"Duke University Hospital","Durham","North Carolina","27710",{"type":114,"coordinates":218},[219,220],-78.89862,35.99403,{"lat":220,"lon":219},[223],{"name":224,"role":101,"phone":225,"phoneExt":11,"email":226},"Stephanie Bryant","(919) 668-4777","stephanie.l.bryant@duke.edu",{"facility":228,"status":107,"city":229,"state":230,"zip":231,"country":111,"countryCode":112,"cosmosGeoPoint":232,"geoPoint":236,"contacts":237},"Vanderbilt University Medical Center","Nashville","Tennessee","37232",{"type":114,"coordinates":233},[234,235],-86.78444,36.16589,{"lat":235,"lon":234},[238],{"name":239,"role":101,"phone":240,"phoneExt":11,"email":241},"LeeAnna Melton","(615) 322-7601","leeanna.melton@vumc.org",{"facility":243,"status":107,"city":244,"state":245,"zip":246,"country":111,"countryCode":112,"cosmosGeoPoint":247,"geoPoint":251,"contacts":252},"Children's Medical Center, Dallas","Dallas","Texas","75235",{"type":114,"coordinates":248},[249,250],-96.80667,32.78306,{"lat":250,"lon":249},[253],{"name":254,"role":101,"phone":255,"phoneExt":11,"email":256},"Colton Youngblood","(214) 456-3163","Colten.Youngblood@childrens.com",{"facility":258,"status":107,"city":259,"state":245,"zip":260,"country":111,"countryCode":112,"cosmosGeoPoint":261,"geoPoint":265,"contacts":266},"University of Texas Health Science Center Medical School at Houston","Houston","77030",{"type":114,"coordinates":262},[263,264],-95.36327,29.76328,{"lat":264,"lon":263},[267],{"name":268,"role":101,"phone":269,"phoneExt":11,"email":270},"Heather Saavedra","(713) 500-7098","heather.saavedra@uth.tmc.edu",{"facility":272,"status":107,"city":273,"state":274,"zip":275,"country":111,"countryCode":112,"cosmosGeoPoint":276,"geoPoint":280,"contacts":281},"University of Wisconsin-Madison","Madison","Wisconsin","53715",{"type":114,"coordinates":277},[278,279],-89.40123,43.07305,{"lat":279,"lon":278},[282],{"name":283,"role":101,"phone":284,"phoneExt":11,"email":285},"Sarah M Heitmeier","(608) 263-8863","sheitmeier@wisc.edu",{"facility":287,"status":107,"city":288,"state":289,"zip":290,"country":291,"countryCode":292,"cosmosGeoPoint":293,"geoPoint":297,"contacts":298},"The Children's Hospital at Westmead","Westmead","New South Wales","2145","Australia","AU",{"type":114,"coordinates":294},[295,296],150.98768,-33.80383,{"lat":296,"lon":295},[299],{"name":300,"role":101,"phone":301,"phoneExt":11,"email":302},"Abani Surendran","61294631868","abani.surendran@health.nsw.gov.au",{"facility":304,"status":107,"city":305,"state":306,"zip":307,"country":291,"countryCode":292,"cosmosGeoPoint":308,"geoPoint":312,"contacts":313},"Royal Children's Hospital","Parkville","Victoria","3052",{"type":114,"coordinates":309},[310,311],144.95,-37.78333,{"lat":311,"lon":310},[314],{"name":315,"role":101,"phone":11,"phoneExt":11,"email":316},"Raj Supriya","supriya.raj@mcri.edu.au",{"facility":318,"status":107,"city":319,"state":320,"zip":321,"country":322,"countryCode":323,"cosmosGeoPoint":324,"geoPoint":328,"contacts":329},"Women's and Children's Health Research Institute, University of Alberta","Edmonton","Alberta","T6G 2R3","Canada","CA",{"type":114,"coordinates":325},[326,327],-113.46871,53.55014,{"lat":327,"lon":326},[330],{"name":331,"role":101,"phone":332,"phoneExt":11,"email":333},"Lee-Ann Carroll","(780) 248-5616","lee-ann.carroll@albertahealthservices.ca",{"facility":335,"status":107,"city":336,"state":337,"zip":338,"country":322,"countryCode":323,"cosmosGeoPoint":339,"geoPoint":343,"contacts":344},"Children's Hospital of Eastern Ontario","Ottawa","Ontario","K1H 8L1",{"type":114,"coordinates":340},[341,342],-75.69812,45.41117,{"lat":342,"lon":341},[345],{"name":346,"role":101,"phone":347,"phoneExt":11,"email":348},"Nasrin Khan","(613) 737-7600 ext 4119","NaKhan@cheo.on.ca",{"facility":350,"status":107,"city":351,"state":337,"zip":352,"country":322,"countryCode":323,"cosmosGeoPoint":353,"geoPoint":357,"contacts":358},"The Hospital for Sick Children","Toronto","M5G1X8",{"type":114,"coordinates":354},[355,356],-79.39864,43.70643,{"lat":356,"lon":355},[359],{"name":360,"role":101,"phone":361,"phoneExt":362,"email":363},"Tony Tan","(416) 813 7654","x203575","tony.tan@sickkids.ca",{"facility":365,"status":107,"city":366,"state":367,"zip":368,"country":369,"countryCode":370,"cosmosGeoPoint":371,"geoPoint":375,"contacts":376},"Unidad de Cirugía Artroscópica (MIKS Hospital)","Vitoria-Gasteiz","Alava","1008","Spain","ES",{"type":114,"coordinates":372},[373,374],-2.67268,42.84998,{"lat":374,"lon":373},[377],{"name":378,"role":101,"phone":379,"phoneExt":11,"email":380},"Irene Gimeno Lluch","34610984309","irene.gimeno@ucatrauma.com",{"facility":382,"status":107,"city":383,"state":11,"zip":11,"country":384,"countryCode":385,"cosmosGeoPoint":386,"geoPoint":390,"contacts":391},"Astrid Lindgren Children's Hospital (Karolinska University Hospital)","Stockholm","Sweden","SE",{"type":114,"coordinates":387},[388,389],18.06871,59.32938,{"lat":389,"lon":388},[392],{"name":393,"role":101,"phone":394,"phoneExt":11,"email":395},"Ola Nilsson","+46 8 5248 2425","ola.nilsson@ki.se",{"type":397,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100053332","phase-2-a-study-of-tyra-300-in-children-with-achondroplasia-beach301-100053332",false,"NCT06842355","A Study of TYRA-300 in Children With Achondroplasia: BEACH301","A Multicenter, Phase 2, Dose-Escalation\u002FDose-Expansion Study of TYRA-300 in Children With Achondroplasia With Open Growth Plates: BEACH301","Inclusion Criteria:\n\n* Aged 3 to 10 years old (inclusive) at the time of consent.\n* Informed consent provided by parent(s) or legal guardian(s). As study participants are less than 18 years old, participants are willing and able to provide written assent (where applicable and required).\n* Molecular diagnosis of achondroplasia (FGFR3 G380R).\n* Radiographically confirmed open growth plates at Screening, as determined by bone age X-ray.\n* Able to stand and ambulate independently.\n* Able to take oral medication.\n* Sentinel Safety Cohort only: aged 5 to 10 years old (inclusive).\n* Cohort 1 only: aged 3 to 10 years old (inclusive) and are naive to prior growth accelerating therapy.\n* Cohort 2 only: aged 3 to 10 years old (inclusive) and have received prior growth accelerating therapy.\n\nExclusion Criteria:\n\n* Presence or history of any concurrent disease or condition that would interfere with study participation, safety evaluations, or any uncontrolled or untreated condition that could impact pediatric growth.\n* Diagnosis of endocrine condition that alters calcium\u002Fphosphate homeostasis.\n* Prior limb lengthening surgery or planned or expected to have limb lengthening surgery while enrolled in the study.\n* Taking medications that are strong inhibitors or inducers of cytochrome P450 (Cyp) 3A4.\n* History or current evidence of corneal or retinal disorder\u002Fkeratopathy.\n* Presence of guided growth hardware\u002F8 plates. Planned or anticipated orthopedic surgeries.","ALL","3 Years","10 Years",{"count":409,"type":410},92,"ESTIMATED","INTERVENTIONAL",[413],"PHASE2","The purpose of this study is to evaluate the safety, tolerability, and identify potentially effective dose(s) of TYRA-300 in children with achondroplasia with open growth plates.",[416],"Achondroplasia","2026-07-09",{"date":419,"type":420},"2026-07-13","ACTUAL",{"date":422,"type":420},"2025-03-04",{"date":424,"type":410},"2030-06",{"name":5,"class":6},19]