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A Phase 1, 2-Part Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of ASLAN003 in Healthy Elderly Subjects

NCT02342652 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2016-11-02

No results posted yet for this study

Summary

This is a Phase 1, randomised, single-blind, placebo-controlled, 2 stage study design with 2 multiple dose cohorts of healthy elderly subjects.

The purpose of the study is to determine the safety, tolerability and pharmacokinetics of ASLAN003 in healthy elderly male and female subjects.

Conditions

  • Healthy Elderly Subjects (Age ≥55 Years)

Interventions

DRUG

ASLAN003

Healthy subject will be randomised to receive either ASLAN003 (N-aryl substituted aminoaryloic acid derivative), which is a DHODH inhibitor developed with the aim of improving several features of teriflunomide or the matching placebo as a negative control for each dose of ASLAN003 administered.

DRUG

Matched Placebo

Healthy subject will be randomised to receive either ASLAN003 (N-aryl substituted aminoaryloic acid derivative), which is a DHODH inhibitor developed with the aim of improving several features of teriflunomide or the matching placebo as a negative control for each dose of ASLAN003 administered.

Sponsors & Collaborators

  • ASLAN Pharmaceuticals

    lead OTHER

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • Singapore

Study Locations

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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 NCT02342652 on ClinicalTrials.gov