An Interventional Study of Infigratinib in Children With Hypochondroplasia

Exclusion Criteria

• •Participants who have ACH or a short stature condition other than HCH.
• •Significant concurrent disease or condition that, in the view of the investigator and/or sponsor, would confound assessment of efficacy or safety of infigratinib.
• •Current evidence of clinically significant corneal or retinal disorder/keratopathy confirmed by ophthalmic examination.
• •Concurrent circumstance, disease, or condition that, in the view of the investigator and/or sponsor, would interfere with study participation or safety evaluations.
• •History and/or current evidence of extensive ectopic tissue calcification.
• •History of malignancy.
• •Having received or planning to receive treatment with any other investigational or approved product for the treatment of ACH, HCH, or short stature.
• •Regular long-term treatment (≥3 weeks) with supraphysiologic doses of glucocorticoid.
• •Previous limb-lengthening surgery at any time or planned/expected to have limb-lengthening or guided growth surgery while participating in the study.
• •Participants receiving medications which could increase serum phosphorus and/or calcium concentrations
• •Clinically significant abnormality in any laboratory test result at screening.
• •Pregnant or breastfeeding at the screening visit or planning to become pregnant (self or partner) at any time during the study.
• •Allergy to any components of the study drug.
• •Concurrent circumstance, disease, or condition that would interfere with study participation.