A Study of TYRA-300 in Children With Achondroplasia: BEACH301

Recruiting now · Phase 2

Conditions studied: Achondroplasia

In brief

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.

Key facts

Study ID

NCT06842355

Run by

Tyra Biosciences, Inc

People needed

92

Starts

2025-03-04

Expected to finish

2030-06-01

Last updated by the study team

2026-07-31

Who can join

Age: 3 and older, up to 10. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged 3 to 10 years old (inclusive) at the time of consent.
• 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).
• Molecular diagnosis of achondroplasia (FGFR3 G380R).
• Radiographically confirmed open growth plates at Screening, as determined by bone age X-ray.
• Able to stand and ambulate independently.
• Able to take oral medication.
• Sentinel Safety Cohort only: aged 5 to 10 years old (inclusive).
• Cohort 1 only: aged 3 to 10 years old (inclusive) and are naive to prior growth accelerating therapy.
• Cohort 2 only: aged 3 to 10 years old (inclusive) and have received prior growth accelerating therapy.

You may not qualify if…

• 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.
• Diagnosis of endocrine condition that alters calcium/phosphate homeostasis.
• Prior limb lengthening surgery or planned or expected to have limb lengthening surgery while enrolled in the study.
• Taking medications that are strong inhibitors or inducers of cytochrome P450 (Cyp) 3A4.
• History or current evidence of corneal or retinal disorder/keratopathy.
• Presence of guided growth hardware/8 plates. Planned or anticipated orthopedic surgeries.

Where it is running

• Lundquist Institute for Biomedical Innovation — Torrance, California, United States (enrolling)
• Children's Hospital Colorado — Aurora, Colorado, United States (enrolling)
• Nemours Alfred I duPont Hospital for Children — Wilmington, Delaware, United States (enrolling)
• Johns Hopkins University School of Medicine — Baltimore, Maryland, United States (enrolling)
• Uncommon Cures — Chevy Chase, Maryland, United States (enrolling)
• University of Missouri — Columbia, Missouri, United States (enrolling)
• Washington University — St Louis, Missouri, United States (enrolling)
• Duke University Hospital — Durham, North Carolina, United States (enrolling)
• Vanderbilt University Medical Center — Nashville, Tennessee, United States (enrolling)
• Children's Medical Center, Dallas — Dallas, Texas, United States (enrolling)
• University of Texas Health Science Center Medical School at Houston — Houston, Texas, United States (enrolling)
• University of Wisconsin-Madison — Madison, Wisconsin, United States (enrolling)
• The Children's Hospital at Westmead — Westmead, New South Wales, Australia (enrolling)
• Royal Children's Hospital — Parkville, Victoria, Australia (enrolling)
• Women's and Children's Health Research Institute, University of Alberta — Edmonton, Alberta, Canada (enrolling)
• Children's Hospital of Eastern Ontario — Ottawa, Ontario, Canada (enrolling)
• The Hospital for Sick Children — Toronto, Ontario, Canada (enrolling)
• Imagine Institute — Paris, France (enrolling)
• UMC Utrecht — Utrecht, Netherlands (enrolling)
• Unidad de Cirugía Artroscópica (MIKS Hospital) — Vitoria-Gasteiz, Alava, Spain (enrolling)
• Hospital Univeristario La Paz — Madrid, Madrid, Spain (enrolling)
• Astrid Lindgren Children's Hospital (Karolinska University Hospital) — Stockholm, Sweden (enrolling)
• Great Ormond Street Hospital — London, Greater London, United Kingdom (enrolling)
• Sheffield Children's Hospital — Sheffield, South Yorkshire, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.