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

Ionis Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Elevated Triglycerides (TG)

Treatments

Drug: Placebo Comparator

Drug: APOC-III-L-Rx

Study type

Interventional

Funder types

Industry

Identifiers

IONIs-ApoCIII-LRx

Details and patient eligibility

About

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

Enrollment

56 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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