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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
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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | placebo arm |
|
| ASLAN003 | Other | Active drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASLAN003 ACTIVE | Drug | This is a single-centre, placebo-controlled, randomised, double-blind study involving SAD and MAD of ASLAN003 in healthy subjects. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Safety assessments will include 12 lead ECGs, physical examiniation, vital signs measurements, pulse rate, RR, body temperature, clinical laboratory assessments and recording of adverse events | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Please contact ASLAN Pharmaceuticals Pte Ltd | contact@aslanpharma.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Singapore | Singapore |
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