Elevated Triglycerides (TG)
Conditions
Brief summary
The purpose is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of IONIS APOC-III-LRx given to healthy volunteer subjects.
Interventions
DRUGAPOC-III-L-Rx
Ascending single and multiple doses of IONIS-APOC-III-LRx by subcutaneous (SC) injection
DRUGPlacebo Comparator
Sterile Normal Saline (0.9% NaCl) calculated volume to match active comparator
Sponsors
Akcea Therapeutics
Ionis Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Must have given written informed consent and be able to comply with all study requirements * Healthy males or females aged 18-65 inclusive * Females must be non-pregnant and non-lactating, and either surgically sterile or post- menopausal * Males must be surgically sterile, abstinent or using an acceptable contraceptive method * BMI \< 35.0 kg/m2 * Subjects must have Fasting TG ≥ 90 mg/dL or ≥ 200 mg/dL depending on Cohort assignment
Exclusion criteria
* Known history of or positive test for human immunodeficiency virus (HIV), hepatitis C or chronic hepatitis B * Treatment with another Study Drug, biological agent, or device within one-month of screening * Regular excessive use of alcohol within 6 months of Screening * Use of concomitant drugs unless authorized by the Sponsor Medical Monitor * Smoking \> 10 cigarettes a day * Considered unsuitable for inclusion by the Principal Investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the safety and tolerability of single and multiple doses of IONIS- APOC-III-LRx - (incidence, severity, and dose-relationship of adverse effects and changes in the laboratory parameters) | Up to 183 days | The safety and tolerability of IONIS- APOC-III-LRx will be assessed by determining the incidence, severity, and dose relationship of adverse effects and changes in the laboratory parameters by dose. Safety results in subjects dosed with IONIS APOC-III-LRx will be compared with those from subjects dosed with placebo. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the plasma pharmacokinetics of single and multiple doses of IONIS- APOC-III-LRx | Up to 183 days | The maximum area under the curve (AUC) of IONIS- APOC-III-LRx will be assessed following single and multiple- dose SC administration |
| To evaluate the urine pharmacokinetics of single and multiple doses of IONIS¬-APOC-III-LRx | Up to 183 days | The amount of IONIS-APOC-III-LRx excreted in urine at selected 24-hour intervals \[Ae0-24h\] will be determined. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exploratory pharmacodynamic effects of IONIS-APOC-III-LRx | Up to 183 days | Effects of IONIS-APOC-III-LRx on changes in levels of oxidized phospholipids associated with plasma apolipoprotein C-III (apoC-III) compared to baseline. |
Countries
Canada
Outcome results
None listed