- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Texas
-
College Station, Texas, United States, 77845
- J&S Studies, Inc
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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.
|
|
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.
|
OLT1177 Gel - 3% or 5% administered topically to a defined area of one knee
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recording of adverse events
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
|
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. |
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
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Terry M Jones, MD, J&S Studies
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OLT1177-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy Volunteers
-
AstraZenecaCompletedHealthy Elderly Volunteers | Healthy Young VolunteersUnited States
-
Syndax PharmaceuticalsCompletedHealthy Volunteers | Volunteers | Normal Volunteers | Human VolunteersUnited States
-
Syndax PharmaceuticalsCompletedHealthy Volunteers | Volunteers | Normal Volunteers | Human VolunteersUnited States
-
University Hospital, Clermont-FerrandUnite de Nutrition Humaine UMR 1019- INRAE; Unite MetaGenoPolis INRAE; France...CompletedHealthy Volunteers | Frail VolunteersFrance
-
Newcastle UniversityCompletedGI Glycaemic Index Healthy Volunteers | GL Glycaemic Load Healthy VolunteersUnited Kingdom
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
Galera Therapeutics, Inc.CelerionCompletedHealthy | Healthy VolunteersUnited States
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
PMV Pharmaceuticals, IncRecruitingHealthy VolunteersUnited States
Clinical Trials on Placebo gel
-
Starpharma Pty LtdNational Institute of Allergy and Infectious Diseases (NIAID); Eunice Kennedy... and other collaboratorsCompletedHealthyUnited States, Puerto Rico
-
NutravaliaSlb PharmaCompletedOverweight and ObesityFrance
-
E-nitiate Biopharmaceuticals (Hangzhou) Co., Ltd.Recruiting
-
Topokine Therapeutics, Inc.SuspendedExcess Submental Fat ("Double Chin")
-
Population CouncilCompletedHIV InfectionUnited States
-
Xinnate ABRegion SkaneCompletedBlister | Epidermolysis Bullosa | Wound of Skin | Varicose Ulcer of Lower LimbSweden
-
Starpharma Pty LtdCompletedRecurrent Bacterial Vaginosis (BV)
-
Starpharma Pty LtdCompletedBacterial VaginosisUnited States
-
Suzhou Kintor Pharmaceutical Inc,CompletedAcne Vulgaris | Androgenetic AlopeciaUnited States
-
Kalypsys, Inc.CompletedNeuropathic Pain | Herpes Zoster | Postherpetic Neuralgia | ShinglesUnited States