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

Phase 1

Completed

• Conditions: Elevated Triglycerides (TG)
• Interventions: Drug: Placebo Comparator; Drug: APOC-III-L-Rx

• Registration Number: NCT02900027
• Lead Sponsor: Ionis Pharmaceuticals, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-23
• Study Start: 2016-09
• Study First Submitted QC: 2016-09-13
• Study First Posted: 2016-09-14
• Primary Completion: 2018-04-30
• Study Completion: 2018-04-30
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-18
• Last Update Posted: 2018-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IONIS-APOC-III-LRx	Placebo Comparator	Ascending single and multiple doses of IONIS-APOC-III-LRx by subcutaneous (SC) injection
Placebo (Normal Saline)	APOC-III-L-Rx	Sterile Normal Saline (0.9% NaCl) calculated volume to match active comparator

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
To evaluate the plasma pharmacokinetics of single and multiple doses of IONIS- APOC-III-LRx	Up to 183 days	The maximum time to Cmax (Tmax) 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.

Trial Locations

Locations (1)

BioPharma Services; 🇨🇦 Toronto, Ontario, Canada