Phase 1 Safety Study of Single and Multi-Dose Topically Applied OLT1177 Gel in Healthy Subjects

Healthy Volunteers Clinical Trial

Official title: A Phase 1, Randomized, Dose Escalation, Single Center, Safety Study of Single and Multi-Dose, Topically Applied OLT1177 Gel in Healthy Subjects

Status Completed

Clinical Trial Summary

The purpose of this study is to determine if OLT1177 Gel is safe and can be tolerated when given as a single dose and multidose to a defined area of one knee of healthy subjects.

Clinical Trial Description

OLT1177 Gel is being developed for the topical treatment of pain and inflammation emanating from musculoskeletal and certain skin inflammatory conditions.

This is a Phase 1 study evaluating the safety and tolerability of OLT1177 Gel in healthy subjects when given as single-dose or multi-dose applications. The study will be conducted in two parts, Part A and Part B. In Part A, approximately 18 healthy subjects in 3 dose escalating cohorts will be randomized to receive a single dose of the investigational drug (5 subjects OLT1177 Gel and 1 subject placebo gel). Upon completion of Part A, a new subject population of approximately 18 subjects in 3 dose escalating cohorts will be randomized in Part B of the study. Subjects will receive a total of 8 doses over 3 consecutive days given 6 hours apart while awake during the day and will be followed for up to 30 days for safety assessment. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

• NCT number: NCT01636141
• Study type: Interventional
• Source: Olatec Industries LLC
• Status: Completed
• Phase: Phase 1
• Start date: June 2012
• Completion date: August 2012