Status:
COMPLETED
Examination of Dermatologic Effects From Subcutaneous Injections of ISIS 113715
Lead Sponsor:
Ionis Pharmaceuticals, Inc.
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
10 healthy volunteers will be enrolled to each receive two subcutaneous injections of ISIS 113715 in the abdomen on Study Day 1. Each subject will receive their two injections within a 5-minute period...
Detailed Description
Following a two-week period for subject screening, 10 eligible subjects will be dosed subcutaneously with ISIS 113715 on a single calendar date (Study Day 1). Each subject will receive two subcutaneou...
Eligibility Criteria
Inclusion
- Male or female: Females are post menopausal or surgically sterile; Males are surgically sterile, abstinent, or utilizing an acceptable barrier contraceptive method. Must also agree to continue abstinence and/or to use an acceptable barrier contraceptive method for at least four weeks after their injections of ISIS 113715
- Aged 18 to 65 years
- Weight \> 50 kg
- Body mass index \> 29 kg/m²
Exclusion
- Pregnant, breastfeeding, or intends to become pregnant
- Positive hepatitis B virus, hepatitis C virus, or HIV test
- History of clinical significant abnormalities in complement or coagulation parameters or taking medication that may affect coagulation (e.g., heparin, warfarin), except aspirin or non-steroidal anti-inflammatory agents (NSAID)
- Current or history of significant skin disorders
- History of alcohol or drug abuse
- History of liver or renal disease
- Malignancy (with the exception of basal or squamous cell carcinoma of the skin if adequately treated and no recurrence for \> one year)
- Liver function tests greater than the Upper Limit of Normal (ULN)
- Clinically significant and currently active diseases or active infection requiring antiviral or antimicrobial therapy
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
End Date :
September 1 2006
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00365781
Start Date
August 1 2006
End Date
September 1 2006
Last Update
October 17 2007
Active Locations (1)
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1
Therapeutics Clinical Research
San Diego, California, United States, 92121