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

Sponsor

Olatec Therapeutics LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT01636141

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: OLT1177 Gel Drug: Placebo gel	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2012

Actual Primary Completion Date :

Aug 1, 2012

Actual Study Completion Date :

Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 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: Placebo gel
Active Comparator: OLT1177 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

Arm

Intervention/Treatment

Placebo Comparator: 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: Placebo gel

Active Comparator: OLT1177 Gel

Drug: OLT1177 Gel

OLT1177 Gel - 3% or 5% administered topically to a defined area of one knee

Outcome Measures

Primary Outcome Measures

Recording of adverse events [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]
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.

Secondary Outcome Measures

Area under the Concentration curve (AUC) [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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