NCT03315494

Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of SKI-O-703 in Healthy Volunteers

A Phase 1, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of SKI-O-703 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Oscotec Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This double-blind, placebo-controlled, multiple ascending dose study is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of SKI-O-703 in healthy volunteers.

Detailed description

This is a double-blind, placebo-controlled study in healthy adult volunteers, to evaluate the safety, tolerability, and pharmacokinetics (PK) of multiple ascending doses of SKI-O-703. A total of 24 subjects are planned to participate in 3 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 with a 200 mg once daily (QD) dose cohort and escalated to 400 mg QD, under fasting conditions, for 7 days. In the third cohort, a 200 mg twice daily (BID) dose will be studied for 7 days. Evening dosing will occur 12 hours after the morning dose and will be preceded by fasting for at least 3 hours. After all 8 subjects in each cohort have received the study drug and been monitored, the decision to escalate to the next dose cohort will be made.

Conditions

• Arthritis, Rheumatoid

Interventions

Type	Name	Description
DRUG	SKI-O-703 capsule	SKI-O-703 200 mg capsule with no inactive excipients.
DRUG	Placebo capsule	Placebo 180 mg capsule filled with microcrystalline cellulose.

Timeline

• Start date: 2016-09-22
• Primary completion: 2016-12-21
• Completion: 2016-12-21
• First posted: 2017-10-20
• Last updated: 2017-10-20

Locations

1 site across 1 country: United States