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

Part of paid clinical trials in Torrance, California.

Sponsor
Tyra Biosciences, Inc
Study ID
NCT06842355
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Achondroplasia

Eligibility Criteria

Sex
ALL
Age
3 Years - 10 Years
Healthy Volunteers
Not accepted

Interventions

  • TYRA-300 0.125 mg/kg — DRUG
    Initial dose level of TYRA-300 per protocol, subsequent dose level escalations will occur based on criteria outlined in the protocol.
  • TYRA-300 0.25 mg/kg — DRUG
    Subsequent dose level escalations will occur based on criteria outlined in the protocol.
  • TYRA-300 0.375 mg/kg — DRUG
    Subsequent dose level escalations will occur based on criteria outlined in the protocol.
  • TYRA-300 0.50 mg/kg — DRUG
    Subsequent dose level escalations will occur based on criteria outlined in the protocol.

Study Details

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 Dates

Start date
Mar 4, 2025
Status verified
Jun 2026
Primary completion
Jan 31, 2030
Completion
Jun 30, 2030

Study Design

Enrollment
92 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: TYRA-300 0.125 mg/kg
    TYRA-300 is provided as sprinkle capsules/mini-tablets. The total dose will be calculated based on the participant's weight. Weight adjustments will be made every 3 months.
  • Experimental: TYRA-300 0.25 mg/kg
    TYRA-300 is provided as sprinkle capsules/mini-tablets. The total dose will be calculated based on the participant's weight. Weight adjustments will be made every 3 months.
  • Experimental: TYRA-300 0.375 mg/kg
    TYRA-300 is provided as sprinkle capsules/mini-tablets. The total dose will be calculated based on the participant's weight. Weight adjustments will be made every 3 months.
  • Experimental: TYRA-300 0.50 mg/kg
    TYRA-300 is provided as sprinkle capsules/mini-tablets. The total dose will be calculated based on the participant's weight. Weight adjustments will be made every 3 months.

Primary Outcome Measure

Incidence of treatment-related adverse events as assessed by CTCAE v5.0 [ Time Frame: Up to 12 months ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
Lundquist Institute for Biomedical InnovationTorranceCalifornia90502
Adolfo Morales Garval
[email protected]
(310) 222-3472
Children's Hospital ColoradoAuroraColorado80045
Lauren Samz
[email protected]
720-777-1975
Nemours Alfred I duPont Hospital for ChildrenWilmingtonDelaware19803
Judith Feinson
[email protected]
(302) 651-5928
Johns Hopkins University School of MedicineBaltimoreMaryland21205
Plamena Simeonova, MD
[email protected]
410-614-0977
Uncommon CuresChevy ChaseMaryland20815
Tamanna Roshan Lal
[email protected]
240 858 4938
University of MissouriColumbiaMissouri65201
Taylor Matthews
[email protected]
573-882-4758
Washington UniversitySt LouisMissouri63130
Michelle Ritter
[email protected]
(314) 362-7306
Vanderbilt University Medical CenterNashvilleTennessee37232
LeeAnna Melton
[email protected]
(615) 322-7601
Children's Medical Center, DallasDallasTexas75235
Colton Youngblood
[email protected]
(214) 456-3163
University of Texas Health Science Center Medical School at HoustonHoustonTexas77030
Heather Saavedra
[email protected]
(713) 500-7098
University of Wisconsin-MadisonMadisonWisconsin53715
Sarah M Heitmeier
[email protected]
(608) 263-8863

Find similar trials in Torrance, CA

By research site
Lundquist Institute for Biomedical Innovation· Torrance, CAChildren's Hospital Colorado· Aurora, CONemours Alfred I duPont Hospital for Children· Wilmington, DEJohns Hopkins University School of Medicine· Baltimore, MDUncommon Cures· Chevy Chase, MDUniversity of Missouri· Columbia, MO

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