NCT01636141

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Olatec Therapeutics LLC · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	OLT1177 Gel	OLT1177 Gel - 3% or 5% administered topically to a defined area of one knee
DRUG	Placebo gel

Timeline

• Start date: 2012-06-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2012-07-10
• Last updated: 2012-09-06

Locations

1 site across 1 country: United States