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Study of AC0058TA in Patients With Systemic Lupus Erythematosus (SLE)

NCT03878303 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2019-03-18

No results posted yet for this study

Summary

This is a Phase 1b, double blind, randomized, placebo-controlled study of the safety and tolerability, pharmacokinetics and pharmacodynamics of AC0058TA in patients with systemic lupus erythematosus (SLE).

Conditions

Interventions

DRUG

AC0058TA

25 mg capsules

DRUG

Placebo AC0058TA

equivalent dose of investigational product

Sponsors & Collaborators

  • Hangzhou ACEA Pharmaceutical Research Co., Ltd.

    collaborator INDUSTRY

  • ACEA Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Roy Fleischmann, MD MACR · Metroplex Clinical Research Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-28
Primary Completion
2020-12-31
Completion
2021-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03878303 on ClinicalTrials.gov