Clinical Trial

A Study of ABSK061 to Assess Safety, Tolerability, Pharmacokinetics, and Efficacy in Children With Achondroplasia

Not Yet Recruiting Phase 1/2
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Summary
This is a multicenter, non-randomized, open-label, phase I/II study in children with ACH. This study will start with a dose escalation of ABSK061 in children with ACH to evaluate the safety, tolerability, PK, and efficacy. The RDE confirmation part will evaluate the safety and efficacy of ABSK061 at the recommended doses for expansion (RDEs) in children with ACH. All patients enrolled in the dose escalation part and RDE confirmation part can enter the extended treatment period to further evaluate the long-term safety, tolerability, and long-term efficacy of ABSK061 in children with ACH.
Trial Details
NCT Number NCT07297875
Lead Sponsor Abbisko Therapeutics Co, Ltd
Conditions Achondroplasia
Enrollment 110 participants
Start Date 2025-12-10
Primary Completion 2028-12-15 (estimated)
Study Completion 2031-03-15 (estimated)
Updated on ClinicalTrials.gov 2025-12-22