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

NCT03315494 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-10-20

No results posted yet for this study

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.

Conditions

  • Arthritis, Rheumatoid

Interventions

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.

Sponsors & Collaborators

  • PPD Development, LP

    collaborator INDUSTRY

  • Oscotec Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-22
Primary Completion
2016-12-21
Completion
2016-12-21

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03315494 on ClinicalTrials.gov