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NCT02847325 · ClinicalTrials.gov registry record · Phase 1

Study of AC0058TA in Healthy Male and Female Subjects

A Phase 1 study of Healthy Volunteers, sponsored by ACEA Therapeutics.

Completed
Registry status
Phase 1
Development phase
56
Enrollment target
1
Study location

NCT02847325 is a Phase 1 study of Healthy Volunteers that has completed, run by ACEA Therapeutics. The registered enrollment target is 56 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT02847325, a Phase 1 study of Healthy Volunteers, has completed, sponsored by ACEA Therapeutics.

COMPLETED
Registry status
Phase 1
Development phase
56 participants
Enrollment target
1
Study location

Study 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.

Conditions Studied

Interventions

  • DRUG Placebo capsules
  • DRUG AC0058TA

Study Locations (1)

Texas

  • Covance Clinical Development Services - Dallas

Trial Details

FieldValue
Enrollment Target 56 participants
Start Date 2016-05
Est. Completion 2017-04
Phase Phase 1

Sponsor

ACEA Therapeutics

2 total trials

What the Registry Record Tells You About NCT02847325

The ClinicalTrials.gov registry entry for NCT02847325 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (88% lower). The listed sponsor is ACEA Therapeutics, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 2 interventions - of which Placebo capsules is the first listed.

NCT02847325 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT02847325 about?

NCT02847325 is a clinical study titled "Study of AC0058TA in Healthy Male and Female Subjects". 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 act...

What is the current status of trial NCT02847325?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2016-05. Estimated completion is 2017-04.

What conditions does trial NCT02847325 study?

This clinical trial studies the following conditions: Healthy Volunteers.

What interventions are being tested in trial NCT02847325?

The interventions under investigation include: Placebo capsules (DRUG), AC0058TA (DRUG).

Who is sponsoring clinical trial NCT02847325?

This trial is sponsored by ACEA Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02847325 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.