drugset
drugset / Trial / NCT02717988

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

NCT02717988 ↗

Phase 1 Completed 48 enrolled Oscotec Inc. PPD Development, LP · collab
RandomizedParallel-groupDouble-blindOther

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.

Timeline

Start
2015-09
Primary completion
2016-03
Completion
2016-03

Drugs

EvaluationDrugModalityDoseRoute
Subject SKI-O-703 Unknown 50 mg Oral
Subject SKI-O-703 Unknown 100 mg Oral
Subject SKI-O-703 Unknown 200 mg Oral
Subject SKI-O-703 Unknown 400 mg Oral
Subject SKI-O-703 Unknown 600 mg Oral
Subject SKI-O-703 Unknown 800 mg Oral

Indications

rheumatoid arthritis