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Hospital)","Stockholm","Sweden","SE",{"type":60,"coordinates":318},[319,320],18.06871,59.32938,{"lat":320,"lon":319},[323],{"name":324,"role":47,"phone":325,"phoneExt":31,"email":326},"Ola Nilsson","+46 8 5248 2425","ola.nilsson@ki.se",{"type":328,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100580826",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":339,"type":340},92,"ESTIMATED","INTERVENTIONAL",[343],"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.",[346],"Achondroplasia","2026-06-27",{"date":349,"type":350},"2026-06-30","ACTUAL",{"date":352,"type":350},"2025-03-04",{"date":354,"type":340},"2030-06",{"name":5,"class":6},18]