View Clinical Trial (Medical Research Study)

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

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Conditions:		Healthy Volunteers
Purpose:		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.
Study Summary:		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.
Criteria:		Inclusion Criteria: - Healthy men and women 18 to 60 years of age - Women of childbearing potential must have a negative urine pregnancy test within 3 days of study enrollment and must agree to use a highly effective form of contraception - Subjects must be in good health as determined by the Investigator based on medical history, ECG, physical examination and safety laboratory test - Ability to provide written informed consent prior to initiation of any study-related procedures, and ability, in the opinion of the Investigator, to comply with all the requirements of the study Exclusion Criteria: - Subjects with a known hypersensitivity to the investigational drug - Subjects who are pregnant or lactating - Participation in any investigational drug or device study and receipt of any investigational drug or device within the immediate 30 days prior to the start of this study - Concurrent or recent use of analgesics, steroids, allergy medications, H2 blockers within 48 hours of the start of the study - Subjects with a prior knee injury or surgery within the last 5 years - Subjects with an active infection or with a fever ≥ 38°C within 3 days of the start of the study - Subjects with a history of, or known to be positive for, HIV, hepatitis B or C - Subjects with uncontrolled hypertension as defined by systolic blood pressure (SBP) > 150 mm/Hg, diastolic blood pressure (DBP) > 100 mm/Hg - Subjects with a wound or skin irritation or any skin condition, e.g., psoriasis in the treatment area - Subjects who are taking prescription medications with the exception of oral or systemic contraceptives - Subjects who have systemic diseases - Subjects who have a history of anaphylactic reactions to any systemic or topical compounds
NCT ID:		NCT01636141
Primary Contact:		Principal Investigator Terry M Jones, MD J&S Studies
Backup Contact:		N/A
Location Contact:		College Station, Texas 77845 United States Jeremy Scott Phone: 979-774-5933 Email: jscott@js-studies.com Site Status: Recruiting

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