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RecruitingPhase 2

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

Tyra Biosciences, Inc · NCT06842355

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 3–10 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
92
US sites recruiting
12
Study start
March 4, 2025
Record last updated
October 1, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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.

Being studied: TYRA-300 0.125 mg/kg; TYRA-300 0.25 mg/kg; TYRA-300 0.375 mg/kg; TYRA-300 0.50 mg/kg; TYRA-300 0.625 mg/kg

Conditions: Achondroplasia

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

  • Lundquist Institute for Biomedical Innovation

    Torrance, CA 90502

    Site contact: Adolfo Morales Garval · (310) 222-3472 · adolfo.morales@lundquist.org

  • Children's Hospital Colorado

    Aurora, CO 80045

    Site contact: Lauren Samz · 720-777-1975 · Lauren.Samz@childrenscolorado.org

  • Nemours Alfred I duPont Hospital for Children

    Wilmington, DE 19803

    Site contact: Judith Feinson · (302) 651-5928 · judith.feinson@nemours.org

  • Johns Hopkins University School of Medicine

    Baltimore, MD 21205

    Site contact: Plamena Simeonova, MD · 410-614-0977 · psimeon1@jh.edu

  • Uncommon Cures

    Chevy Chase, MD 20815

    Site contact: Tamanna Roshan Lal · 240 858 4938 · troshanlal@uncommoncures.com

  • University of Missouri

    Columbia, MO 65201

    Site contact: Taylor Matthews · 573-882-4758 · mathewsta@health.missouri.edu

  • Washington University

    St Louis, MO 63130

    Site contact: Michelle Ritter · (314) 362-7306 · michelle.ritter@wustl.edu

  • Duke University Hospital

    Durham, NC 27710

    Site contact: Stephanie Bryant · (919) 668-4777 · stephanie.l.bryant@duke.edu

  • Vanderbilt University Medical Center

    Nashville, TN 37232

    Site contact: LeeAnna Melton · (615) 322-7601 · leeanna.melton@vumc.org

  • Children's Medical Center, Dallas

    Dallas, TX 75235

    Site contact: Colton Youngblood · (214) 456-3163 · Colten.Youngblood@childrens.com

  • University of Texas Health Science Center Medical School at Houston

    Houston, TX 77030

    Site contact: Heather Saavedra · (713) 500-7098 · heather.saavedra@uth.tmc.edu

  • University of Wisconsin-Madison

    Madison, WI 53715

    Site contact: Sarah M Heitmeier · (608) 263-8863 · sheitmeier@wisc.edu

Study contacts (from the official record)

  • Lara Balick · (929) 792-5633 · tyraclinicaltrials@tyra.bio
A Study of TYRA-300 in Children With Achondroplasia: BEACH301 (NCT06842355) | Bored Studies