A Phase 1 interventional study of ASLAN003 and Matched Placebo in Healthy Elderly Subjects (Age ≥55 Years), sponsored by ASLAN Pharmaceuticals. Completed at 1 site in Singapore. Open to participants aged 55 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-02.
Sponsored by ASLAN Pharmaceuticals · Phase 1, Interventional, and Basic science
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.
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.
ASLAN Pharmaceuticals is the lead sponsor of 20 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Substance: ASLAN003 Administration route: Oral. Dosage form: Hard gelatine 50 mg capsules. Frequency: 100 mg (2 capsules) once daily for 14 consecutive days
Drug: ASLAN003
Substance: Placebo Administration route: Oral Dosage form: Hard gelatine capsules Frequency: 2 capsules once daily for 14 consecutive days
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.
Also known as: LAS186323
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.
Safety (12 lead ECGs, physical examination, vital signs measurements, pulse rate, RR, body temperature, clinical laboratory assessments and recording of adverse events)
Safety assessments will include 12 lead ECGs, physical examination, vital signs measurements, pulse rate, RR, body temperature, clinical laboratory assessments and recording of adverse events
Time frame: 6 months
This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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ASLAN Pharmaceuticals