Phase 1, Randomised Double Blinded Placebo Controlled Study of ASLAN003

Healthy Volunteers Clinical Trial

Official title: A Phase 1, Randomised, Double Blind, Placebo Controlled, 2-Part Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Doses and Multiple Ascending Doses of ASLAN003 in Healthy Subjects

Status Completed

Clinical Trial Summary

This is a single-centre, placebo-controlled, randomised, double-blind study to evaluate the safety and tolerability of single ascending doses (SAD) and multiple ascending doses (MAD) of ASLAN003 in healthy subjects

Clinical Trial Description

This is a single-centre, placebo-controlled, randomised, double-blind study involving SAD and MAD of ASLAN003 in healthy subjects.

The study is divided into two parts:

• Part A: SAD cohorts and 1 cohort to assess food effect of ASLAN003 PK.

• Part B: MAD cohorts with one cohort being of healthy elderly subjects.

There will be a sentinel pair of subjects for each of SAD Cohorts 1, 2 and 3 who will be dosed first and then the same dose will be given to the rest of the subjects in the respective cohorts.

In addition, 8 subjects will receive ASLAN003 under both fed and fasted conditions ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteers

• NCT number: NCT01992367
• Study type: Interventional
• Source: Aslan Pharmaceuticals
• Status: Completed
• Phase: Phase 1
• Start date: August 2013
• Completion date: May 2014