Safety, Tolerability, and Pharmacokinetics of a Single Oral Dose of SKI-O-703 in Healthy Volunteers

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

• NCT number: NCT02717988
• Study type: Interventional
• Source: Oscotec Inc.
• Status: Completed
• Phase: Phase 1
• Start date: September 2015
• Completion date: March 2016