Ignite Creation Date:
2024-05-06 @ 8:19 AM
Last Modification Date:
2024-10-26 @ 11:59 AM
Study NCT ID:
NCT02717988
Status:
COMPLETED
Last Update Posted:
2018-02-28
First Post:
2016-03-04
Brief Title:
Safety Tolerability and Pharmacokinetics of a Single Oral Dose of SKI-O-703 in Healthy Volunteers
Sponsor:
Oscotec Inc
Organization:
Oscotec Inc
Study Overview
Official Title:
A Phase 1 Double-Blind Placebo-Controlled Single Ascending Dose Study to Assess the Safety Tolerability and Pharmacokinetics of a Single Oral Dose of SKI-O-703 in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2017-10
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:
This double-blind placebo-controlled single ascending dose study is designed to demonstrate safety tolerability and pharmacokinetics of SKI-O-703 in healthy volunteers The results of this study will guide selection of dose levels for future multiple dose studies in healthy volunteers and adult patients with moderately to severely active rheumatoid arthritis
Detailed Description:
This is a double-blind placebo-controlled study in healthy adult volunteers that will be conducted to evaluate the safety tolerability and pharmacokinetics of ascending single doses of SKI-O-703 A total of 48 subjects are planned to participate in 6 cohorts 8 subjects each In each cohort 6 subjects will be randomly assigned to receive SKI-O-703 and 2 subjects will be randomly assigned to matching placebo Dosing will be initiated in the 50 mg dose cohort and sequentially escalated to the 100 mg 200 mg 400 mg 600 mg and 800 mg cohorts
Study Oversight
Has Oversight DMC:
None
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?:
None