NCT06842355

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 92 (estimated)
• Sponsor: Tyra Biosciences, Inc · Industry
• Sex: All
• Age: 3 Years – 10 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a Phase 2, multicenter, open-label, dose-escalation study to determine the safety, tolerability, and identify potentially effective dose(s) of TYRA-300, a fibroblast growth factor receptor (FGFR)-3 selective tyrosine kinase inhibitor, in children 3 to 10 years of age with achondroplasia with open growth plates that will examine three cohorts of children: the Sentinel Safety Cohort, Cohort 1, and Cohort 2.

Conditions

• Achondroplasia

Interventions

Type	Name	Description
DRUG	TYRA-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.
DRUG	TYRA-300 0.25 mg/kg	Subsequent dose level escalations will occur based on criteria outlined in the protocol.
DRUG	TYRA-300 0.375 mg/kg	Subsequent dose level escalations will occur based on criteria outlined in the protocol.
DRUG	TYRA-300 0.50 mg/kg	Subsequent dose level escalations will occur based on criteria outlined in the protocol.

Timeline

• Start date: 2025-03-04
• Primary completion: 2030-01-01
• Completion: 2030-06-01
• First posted: 2025-02-24
• Last updated: 2026-03-06

Locations

13 sites across 3 countries: United States, Australia, Canada

Regulatory

• FDA-regulated drug study