NCT06842355 A Study of TYRA-300 in Children With Achondroplasia: BEACH301
| NCT ID | NCT06842355 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Tyra Biosciences, Inc |
| Condition | Achondroplasia |
| Study Type | INTERVENTIONAL |
| Enrollment | 92 participants |
| Start Date | 2025-03-04 |
| Primary Completion | 2030-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 92 participants in total. It began in 2025-03-04 with a primary completion date of 2030-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Doug Warner, MD
STUDY CHAIR
Tyra Biosciences
Frequently Asked Questions
Who can join the NCT06842355 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 10 Years, studying Achondroplasia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06842355 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06842355 currently recruiting?
Yes, NCT06842355 is actively recruiting participants. Contact the research team at ACH@tyra.bio for enrollment information.
Where is the NCT06842355 trial being conducted?
This trial is being conducted at Torrance, United States, Aurora, United States, Wilmington, United States, Baltimore, United States and 11 additional locations.
Who is sponsoring the NCT06842355 clinical trial?
NCT06842355 is sponsored by Tyra Biosciences, Inc. The principal investigator is Doug Warner, MD at Tyra Biosciences. The trial plans to enroll 92 participants.