NCT02342652

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: ASLAN Pharmaceuticals · Academic / Other
• Sex: All
• Age: 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a Phase 1, randomised, single-blind, placebo-controlled, 2 stage study design with 2 multiple dose cohorts of healthy elderly subjects. Randomisation will be in a 3:1 ratio to ensure that 6 subjects receive ASLAN003 and 2 subjects receive placebo in a fed condition. Up to a maximum of 16 subjects (two cohorts) are planned in this study. Subjects will be randomised to receive ASLAN003 100mg or matched placebo once daily for 14 consecutive days. After 8 subjects have completed 14 days of dosing, the Investigator, and the Sponsor will review the available safety and PK data from all subjects before deciding to proceed with stage 2 of the study. In Stage 2, a further 8 subjects will be randomised to receive ASLAN003 100mg or matched placebo once daily for 14 consecutive days. Following a screening visit that must fall within 28 days prior to the first dose of Investigational Product (IP) for both parts, subjects who qualify (according to the protocol-defined inclusion and exclusion criteria) will be admitted to the study centre on Day -1. Dose administration for each study part will commence on Day 1. The subjects will stay at the study centre throughout the 14 days of dosing (D-1 toD15). Full PK blood collection will be done on D1, D8 and D14, and single trough PK blood collection on D4 and D11. All subjects will be discharged on D15 and asked to return for single PK blood sampling on D16, D17, D18, and D19 (+5days post-dose), with full outpatient visit including safety follow up and lab test on Day 19.

Conditions

• Healthy Elderly Subjects (Age ≥55 Years)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-10-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2015-01-21
• Last updated: 2016-11-02

Locations

1 site across 1 country: Singapore