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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-04-30

Brief Summary

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

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Detailed Description

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Conditions

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Elevated Triglycerides (TG)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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IONIS-APOC-III-LRx

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

Group Type EXPERIMENTAL

Placebo Comparator

Intervention Type DRUG

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

Placebo (Normal Saline)

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

Group Type PLACEBO_COMPARATOR

APOC-III-L-Rx

Intervention Type DRUG

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

Interventions

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APOC-III-L-Rx

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

Intervention Type DRUG

Placebo Comparator

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes