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

• Status: Completed
• Trial end date: 2018-04-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ionis Pharmaceuticals, Inc.
• Collaborator: Akcea Therapeutics

Criteria

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