Actively Recruiting

Phase 2
Age: 3Years - 10Years
All Genders
NCT06842355

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

Led by Tyra Biosciences, Inc · Updated on 2026-04-24

92

Participants Needed

15

Research Sites

273 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 3Years - 10Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 3 to 10 years old (inclusive) at the time of consent
  • Informed consent provided by parent(s) or legal guardian(s); participants able to provide written assent if applicable
  • Molecular diagnosis of achondroplasia (FGFR3 G380R)
  • Radiographically confirmed open growth plates at screening
  • Able to stand and walk 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 and naive to prior growth accelerating therapy
  • Cohort 2 only: aged 3 to 10 years old and have received prior growth accelerating therapy
Not Eligible

You will not qualify if you...

  • Any concurrent disease or condition interfering with study participation or safety evaluations
  • Uncontrolled or untreated condition affecting pediatric growth
  • Diagnosis of endocrine condition altering calcium/phosphate balance
  • Prior limb lengthening surgery or plans to have surgery during the study
  • Use of strong inhibitors or inducers of cytochrome P450 3A4
  • History or current corneal, retinal disorder, or keratopathy
  • Presence of guided growth hardware/8 plates or planned orthopedic surgeries

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 15 locations

1

Lundquist Institute for Biomedical Innovation

Torrance, California, United States, 90502

Actively Recruiting

2

Children's Hospital Colorado

Aurora, Colorado, United States, 80045

Actively Recruiting

3

Nemours Alfred I duPont Hospital for Children

Wilmington, Delaware, United States, 19803

Actively Recruiting

4

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States, 21205

Actively Recruiting

5

Uncommon Cures

Chevy Chase, Maryland, United States, 20815

Actively Recruiting

6

University of Missouri

Columbia, Missouri, United States, 65201

Actively Recruiting

7

Washington University

St Louis, Missouri, United States, 63130

Actively Recruiting

8

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232

Actively Recruiting

9

Children's Medical Center, Dallas

Dallas, Texas, United States, 75235

Actively Recruiting

10

University of Texas Health Science Center Medical School at Houston

Houston, Texas, United States, 77030

Actively Recruiting

11

University of Wisconsin-Madison

Madison, Wisconsin, United States, 53715

Actively Recruiting

12

The Children's Hospital at Westmead

Westmead, New South Wales, Australia, 2145

Actively Recruiting

13

Royal Children's Hospital

Parkville, Victoria, Australia, 3052

Actively Recruiting

14

The Hospital for Sick Children

Toronto, Ontario, Canada, M5G1X8

Actively Recruiting

15

Unidad de Cirugía Artroscópica (MIKS Hospital)

Vitoria-Gasteiz, Alava, Spain, 1008

Actively Recruiting

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Research Team

S

Sinette Heys

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

4

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