A Phase 1 interventional study of OLT1177 Gel and Placebo gel in Healthy Volunteers, sponsored by Olatec Therapeutics LLC. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-09-06.
Sponsored by Olatec Therapeutics LLC · Phase 1, Interventional, and Treatment
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.
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.
Olatec Therapeutics LLC is the lead sponsor of 7 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Each study group consists of 6 subjects randomized in a 5:1 ratio to receive OLT1177 Gel or placebo gel in both Part A and B of the study. Eighteen subjects will be enrolled in Part A and 18 in Part B. A total of 30 subjects will receive OLT1177 Gel and 6 subjects will receive placebo gel.
Drug: Placebo gel
Each study group consists of 6 subjects randomized in a 5:1 ratio to receive OLT1177 Gel or placebo gel in both Part A and B of the study. Eighteen subjects will be enrolled in Part A and 18 in Part B. A total of 30 subjects will receive OLT1177 Gel and 6 subjects will receive placebo gel.
Drug: OLT1177 Gel
OLT1177 Gel - 3% or 5% administered topically to a defined area of one knee
Recording of adverse events
Adverse events will be described with respect to seriousness, intensity, relationship to treatment, action taken and outcome of the event. Local skin irritation will be assessed at each visit based on individual signs and symptoms of skin tolerability for erythema, pruritus, scaling/dryness, edema and stinging/burning.
Time frame: Part A - during the 7 days following the application of the study drug and Part B during the 14 day following each application of the study drug
Area under the Concentration curve (AUC)
Time frame: Part A - Pre-dose, 15 minutes, 30 minutes, 1, 2, 4 and 6 hours post dose and Days 2, 3 and 7. Part B - Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, and 6 hours post dose, Days 2, 3 (15 minutes, 30 minutes, 1, 2, 4 and 6 hours post dose) Days 4, 7 and 14
This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.
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Olatec Therapeutics LLC