Safety, Tolerability, PK, and Pharmacodynamics(PD) of IONIS APOCIII-LRx in Healthy Volunteers With Elevated Triglycerides

Ionis Pharmaceuticals, Inc.56 enrolled

Overview

The purpose is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of IONIS APOC-III-LRx given to healthy volunteer subjects.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Elevated Triglycerides (TG)

Interventions

APOC-III-L-RxDRUG

Ascending single and multiple doses of IONIS-APOC-III-LRx by subcutaneous (SC) injection

Placebo ComparatorDRUG

Sterile Normal Saline (0.9% NaCl) calculated volume to match active comparator

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

BioPharma Services

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

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)

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.

Time frame: Up to 183 days

Secondary Outcomes

To evaluate the plasma pharmacokinetics of single and multiple doses of IONIS- APOC-III-LRx

The maximum area under the curve (AUC) of IONIS- APOC-III-LRx will be assessed following single and multiple- dose SC administration

Time frame: Up to 183 days

To evaluate the urine pharmacokinetics of single and multiple doses of IONIS¬-APOC-III-LRx

The amount of IONIS-APOC-III-LRx excreted in urine at selected 24-hour intervals \[Ae0-24h\] will be determined.

Time frame: Up to 183 days

To evaluate the plasma pharmacokinetics of single and multiple doses of IONIS- APOC-III-LRx

The maximum plasma concentration (Cmax) of IONIS- APOC-III-LRx will be assessed following single and multiple- dose SC administration

Time frame: Up to 183 Days

To evaluate the plasma pharmacokinetics of single and multiple doses of IONIS- APOC-III-LRx

The maximum time to Cmax (Tmax) of IONIS- APOC-III-LRx will be assessed following single and multiple-dose SC administration

Time frame: Up to 183 days

Data from ClinicalTrials.gov

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