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Phase 1 Safety and PK Study of OLT1177 Capsules

NCT02134964 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2015-03-06

No results posted yet for this study

Summary

This study is a randomized, placebo-controlled, sequential ascending-dose study of healthy volunteers after administration of single or multiple dose(s) of investigational drug (OLT1177 Caps or Placebo Caps). A total of 36 subjects will be enrolled across 6 cohorts, and subjects in each cohort will be randomized in a ratio of 5 active to 1 placebo.

Conditions

  • Healthy Volunteers

Interventions

DRUG

OLT1177 Capsules

OLT1177 Capsules are an experimental drug.

DRUG

Placebo Capsules

Placebo Capsules are identical in all ways to the study drug, but contain no active pharmaceutical ingredient.

Sponsors & Collaborators

  • Olatec Therapeutics LLC

    lead INDUSTRY

Principal Investigators

  • Terry M Jones, MD, FAAD · J&S Studies

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2014-12-31
Completion
2014-12-31

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 NCT02134964 on ClinicalTrials.gov