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

NCT03838185 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2020-09-03

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

J147

Single oral dose of J147

DRUG

Placebo

Single oral dose of corn oil

Sponsors & Collaborators

  • Iqvia Pty Ltd

    collaborator INDUSTRY

  • Abrexa Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Martin Kankam, MD, PhD, MPH · Vince & Associates Clinical Research, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-22
Primary Completion
2020-02-01
Completion
2020-02-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT03838185 on ClinicalTrials.gov