Examination of Dermatologic Effects From Subcutaneous Injections of ISIS 113715

Ionis Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: ISIS 113715

Study type

Interventional

Funder types

Industry

Identifiers

NCT00365781

ISIS 113715-CS13

Details and patient eligibility

About

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. On Study Days 2 and 8, each subject's injection sites will be assessed for dermatologic effects. The Isis Project Physician(s) will observe the injection sites on Study Day 2 and may also observe on Study Day 8.

Routine clinical chemistry, hematology, and urinalysis tests will be performed on Study Day 1 and Day 8. Subjects will be contacted by telephone on Study Day 30 to monitor for the occurrence of new serious adverse events (SAEs). Thereafter, the subjects will be discharged from the study.

Full 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 subcutaneous injections given within a 5-minute period. The first injection will be 200 mg ISIS 113715 given in 1.0 mL and will be injected about 7.5 cm to the left of the umbilicus. The second injection will be 200 mg ISIS 113715 given in 2.0 mL and will be injected about 7.5 cm to the right of the umbilicus. Both injections will be delivered using 3.0-mL syringes outfitted with 30-gauge, 0.5-inch needles. To further minimize variability, all injections will be performed by a single individual, the Investigator or his designee, employing uniform technique for all of the injections.

Dermatologic responses at injection sites will be assessed at 1 and 7 days after the injections (Study Days 2 and 8, respectively). Effects will be evaluated through completion of the Injection Site Assessment Questionnaires by the Investigator and the recording of adverse events reported by the subject or observed by the Investigator. The Isis Project Physician(s) will observe the injection sites on Study Day 2 and may also observe on Study Day 8.

Routine clinical chemistry, hematology, and urinalysis tests will be performed on Study Days 1 (prior to administration of ISIS 113715) and 8.

Subjects will be contacted by telephone on Study Day 30 to monitor for the occurrence of new serious adverse events. Thereafter, the subjects will be discharged from the study.

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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 criteria

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