drugset / Trial / NCT02847325

Study of AC0058TA in Healthy Male and Female Subjects

NCT02847325 ↗

Phase 1 Completed 56 enrolled ACEA Therapeutics, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

AC0058TA is a small molecule compound that potently, selectively and irreversibly inhibits Bruton's tyrosine kinase (BTK) phosphorylation and downstream signals, resulting in inhibition of inflammatory cytokine production in monocytes and inhibition of lymphocyte activation (predominantly B-cell activation) in the preclinical studies. The nonclinical program has demonstrated that AC0058TA has the potential to interfere with signaling functions mediated by tyrosine kinases and may be useful for controlling excessive or aberrant T- and B-cell activation in autoimmune diseases. As an investigational targeted therapy for RA and SLE, AC0058TA is expected to address the unmet need of this patient population, for whom there are currently no effected therapies and there is a great unmet medical need, AC0058TA may inhibit the key pathway which involves the disease process.

Timeline

Start
2016-05
Primary completion
2017-04
Completion
2017-04

Drugs

EvaluationDrugModalityDoseRoute
Subject AC0058TA Small molecule 50 mg Oral
Subject AC0058TA Small molecule 100 mg Oral
Subject AC0058TA Small molecule 200 mg Oral
Subject AC0058TA Small molecule 400 mg Oral

Indications

No indication recorded.