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

RecruitingPhase 2

A Multicenter, Phase 2, Dose-Escalation/Dose-Expansion Study of TYRA-300 in Children With Achondroplasia With Open Growth Plates: BEACH301

Who can join

Ages 3 to 10 · All sexes

Full eligibility criteria
Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

About the study

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.

What is being tested

Sponsor: Tyra Biosciences, Inc · Participants: 92 · Started: Mar 4, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06842355

Locations in the U.S.

CaliforniaLundquist Institute for Biomedical Innovation, Torrance
ColoradoChildren's Hospital Colorado, Aurora
DelawareNemours Alfred I duPont Hospital for Children, Wilmington
MarylandJohns Hopkins University School of Medicine, Baltimore
Uncommon Cures, Chevy Chase
MissouriUniversity of Missouri, Columbia
Washington University, St Louis
North CarolinaDuke University Hospital, Durham
TennesseeVanderbilt University Medical Center, Nashville
TexasChildren's Medical Center, Dallas, Dallas
University of Texas Health Science Center Medical School at Houston, Houston
WisconsinUniversity of Wisconsin-Madison, Madison

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.