Study of AC0058TA in Healthy Male and Female Subjects

Healthy Volunteers Clinical Trial

Official title: A Phase 1, Randomized Double-Blind, Placebo-Controlled, Single- and Multiple-Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of AC0058TA in Healthy Male and Female Subjects

Status Completed

Clinical Trial 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.

Clinical Trial Description

This is a 2-part, randomized, double-blind, placebo-controlled, single-dose-escalation (Part 1) and multiple-dose-escalation (Part 2) study to evaluate the safety, tolerability, PK, and PD of AC0058TA administered orally to healthy subjects. Part 1 of the study will also to evaluate the effect of food on the pharmacokinetics of a single oral dose of AC0058TA. ;

Related Conditions & MeSH terms

• Healthy Volunteers

• NCT number: NCT02847325
• Study type: Interventional
• Source: ACEA Therapeutics, Inc.
• Status: Completed
• Phase: Phase 1
• Start date: May 2016
• Completion date: April 2017