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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT01636141

Run by

Olatec Therapeutics, Inc.

People needed

36

Starts

2012-06-01

Expected to finish

2012-08-01

Last updated by the study team

2012-09-06

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• J&S Studies, Inc — College Station, Texas, United States

Full record on ClinicalTrials.gov

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