Study to Assess the Safety, Tolerability and Pharmacokinetics of Single Ascending Oral Doses of J147

This is a registry record, not a result. A trial being listed, recruiting or completed says nothing by itself about whether the compound works or is safe.

Registry numberNCT03838185
StatusCompleted
PhasePhase 1
SponsorAbrexa Pharmaceuticals, Inc.
Enrollment64 participants
DesignInterventional, Randomized, Sequential, Masking: Quadruple
ConditionsAlzheimer's Disease
InterventionsJ147; Placebo
StartJan 22, 2019
Primary completionFeb 1, 2020
Study completionFeb 1, 2020
Results postedNot yet
Registry last updatedSep 3, 2020
CollaboratorsIQVIA Pty Ltd

Compounds on this site that cite this trial

What the registry says the trial is about

This Phase I clinical study is a randomized, double-blind, placebo-controlled, parallel-design study to thoroughly assess the safety profile and PK properties of J147 in healthy subjects. The study will include single ascending dose (SAD) in healthy young and elderly subjects.

Primary outcomes

These are what the trial was designed to measure first. They are registered in advance, which is what makes a later result checkable.

Outcome measureTime frame
Incidence of treatment-emergent adverse eventsfrom pre-dose to 7+/-2 days post dose
Number of subjects with abnormal electrocardiogramfrom pre-dose to 7+/-2 days post dose
Incidence of clinically significant changes in serum biomarker levels in a standard serum chemistry panelfrom pre-dose to 7+/-2 days post dose
Incidence of clinically significant changes in hematological biomarker levels in a standard hematology panelfrom pre-dose to 7+/-2 days post dose
Incidence of clinically significant changes in urine biomarker levels in a standard urinalysis panelfrom pre-dose to 7+/-2 days post dose
Number of patients exhibiting changes in standard Physical Examination resultsfrom pre-dose to 7+/-2 days post dose
Number of patients exhibiting changes in standard Neurological Examination resultsfrom pre-dose to 7+/-2 days post dose

7 secondary outcomes also registered. See the registry record for the full list.

Source: ClinicalTrials.gov (U.S. National Library of Medicine). Last checked against the registry on Oct 3, 2026. See the trial changes feed for what has changed recently.