Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2025-12-25 @ 12:28 AM
NCT ID:
NCT01992367
Brief 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
Study:
NCT01992367
Study Brief:
Protocol Section:
NCT01992367