NCT01992367

Phase 1, Randomised Double Blinded Placebo Controlled Study of ASLAN003

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: ASLAN Pharmaceuticals · Academic / Other
• Sex: Male
• Age: 21 Years – 99 Years
• Healthy volunteers: Accepted

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

Detailed 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

Conditions

• Healthy Volunteers

Interventions

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

Timeline

• Start date: 2013-08-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2013-11-25
• Last updated: 2016-11-02

Locations

1 site across 1 country: Singapore