Phase I Reference
Safety and Efficacy Study of Orally Administered DS102 in Healthy Subjects
The citations are from ClinicalTrials.com ( https://clinicaltrials.gov/ct2/show/record/NCT02673593 ). The study identifier is ClinicalTrials.gov Identifier: NCT02673593.
A Randomised, Double-Blind, Placebo-Controlled, Single Ascending Dose and Multiple Dose Phase I Study to Assess the Safety, Pharmacokinetics and Effect of Food on Orally Administered DS102 in Healthy Subjects.
The purpose of the study is to investigate the safety, pharmacokinetics and food effect of DS102 (up to 2000mg single and multiple daily doses) and placebo in healthy participants. DS102 capsules will be orally administered for up to 4 weeks, and will be compared against placebo. The study will enrol approximately 56 adult subjects.
Planimeter was in charge for the eCRF, complete data management, statistical evaluation and reporting.