Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-27 @ 11:00 PM
Study NCT ID:
NCT02673593
Status:
COMPLETED
Last Update Posted:
2016-02-04
First Post:
2016-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of Orally Administered DS102 in Healthy Subjects
Sponsor:
DS Biopharma
Organization:
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
There will be 7 cohorts enrolled, each consisting of 8 subjects.
Cohorts 1 - 4 will be orally administered up to 2000mg single doses of DS102 on Day 1.
Cohorts 5 - 7 will be orally administered up to 2000mg multiple daily doses of DS102 for 28 days.
The primary objective is to assess the safety and plasma pharmacokinetics of single and multiple daily oral doses of DS102.
Cohorts 1 - 4 will be orally administered up to 2000mg single doses of DS102 on Day 1.
Cohorts 5 - 7 will be orally administered up to 2000mg multiple daily doses of DS102 for 28 days.
The primary objective is to assess the safety and plasma pharmacokinetics of single and multiple daily oral doses of DS102.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: