FOP patients harbor mutations in the ALK2 protein (also known as ACVR1) that drives excessive bone morphogenetic protein (BMP) signaling, which regulates cartilage and bone development. INCB000928 is an oral investigational drug designed to target and block this disease-causing mutant FOP protein hyperactivity. In preclinical studies, INCB000928 demonstrated potency for the target kinase, selectivity, safety and strong suppression of heterotopic ossification (HO) in animal models.
About the Clinical Trial
Incyte is currently conducting a
Phase 1
Phase 1: Studies in humans that assess safety and toxicity of a treatment in a small group of healthy volunteers or patients with the disease of interest.
trial with INCB000928 in healthy volunteers (e.g. people without FOP) to establish the safety of the investigational drug. The
Phase 1
Phase 1: Studies in humans that assess safety and toxicity of a treatment in a small group of healthy volunteers or patients with the disease of interest.
trial is evaluating single and multiple ascending doses of oral INCB000928 in healthy volunteers.
Eligibility Criteria*
- AGE: ≥ 18
- DISEASE ACTIVITY: Healthy volunteers only
- MUTATIONS: n/a
Study Design*
- STUDY TYPE: Interventional
- RANDOMIZED STUDY: No
- PLACEBO CONTROLLED: No
- LENGTH OF PARTICIPATION: n/a
- NUMBER OF STUDY VISITS: n/a
Status
Phase 1
