Trial | NCT02900027  Report issue

Title

Safety, Tolerability, PK, and Pharmacodynamics(PD) of IONIS APOCIII-LRx in Healthy Volunteers With Elevated Triglycerides
Placebo-Controlled, Dose-Escalation Study to Assess Safety, Tolerability, PK and PD of a GalNAc3 Conjugated Antisense Oligonucleotide Targeting ApoC-III, Administered Subcutaneously to Healthy Volunteers With Elevated Triglycerides

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    isis 678354 ...

  • Study Participants

    56
The purpose is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of IONIS APOC-III-LRx given to healthy volunteer subjects.
Study Started
Sep 30
2016
Primary Completion
Apr 30
2018
Study Completion
Apr 30
2018
Last Update
May 22
2018

Drug APOC-III-L-Rx

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

Drug Placebo Comparator

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

IONIS-APOC-III-LRx Experimental

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

Placebo (Normal Saline) Placebo Comparator

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

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
No Results Posted