RecruitingPhase 2NCT06842355

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

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

Sponsor

Tyra Biosciences, Inc

Enrollment

92 participants

Start Date

Mar 4, 2025

Study Type

INTERVENTIONAL

Conditions

Achondroplasia

Summary

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.

Eligibility

Min Age: 3 YearsMax Age: 10 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called TYRA-300 0.125 mg/kg, a drug called TYRA-300 0.25 mg/kg, and others for people with achondroplasia. The study is currently recruiting participants at 18 locations. People eligible for this study include aged 3 Years to 10 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTYRA-300 0.125 mg/kg

Initial dose level of TYRA-300 per protocol, subsequent dose level escalations will occur based on criteria outlined in the protocol.

DRUGTYRA-300 0.25 mg/kg

Subsequent dose level escalations will occur based on criteria outlined in the protocol.

DRUGTYRA-300 0.375 mg/kg

Subsequent dose level escalations will occur based on criteria outlined in the protocol.

DRUGTYRA-300 0.50 mg/kg

Subsequent dose level escalations will occur based on criteria outlined in the protocol.

Locations(24)

Lundquist Institute for Biomedical Innovation

Torrance, California, United States

Children's Hospital Colorado

Aurora, Colorado, United States

Nemours Alfred I duPont Hospital for Children

Wilmington, Delaware, United States

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Uncommon Cures

Chevy Chase, Maryland, United States

University of Missouri

Columbia, Missouri, United States

Washington University

St Louis, Missouri, United States

Duke University Hospital

Durham, North Carolina, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Children's Medical Center, Dallas

Dallas, Texas, United States

University of Texas Health Science Center Medical School at Houston

Houston, Texas, United States

University of Wisconsin-Madison

Madison, Wisconsin, United States

The Children's Hospital at Westmead

Westmead, New South Wales, Australia

Royal Children's Hospital

Parkville, Victoria, Australia

Women's and Children's Health Research Institute, University of Alberta

Edmonton, Alberta, Canada

Children's Hospital of Eastern Ontario

Ottawa, Ontario, Canada

The Hospital for Sick Children

Toronto, Ontario, Canada

Imagine Institute

Paris, France

UMC Utrecht

Utrecht, Netherlands

Unidad de Cirugía Artroscópica (MIKS Hospital)

Vitoria-Gasteiz, Alava, Spain

Hospital Univeristario La Paz

Madrid, Madrid, Spain

Astrid Lindgren Children's Hospital (Karolinska University Hospital)

Stockholm, Sweden

Great Ormond Street Hospital

London, Greater London, United Kingdom

Sheffield Children's Hospital

Sheffield, South Yorkshire, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06842355

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