Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IONIS APO(a)-LRx in Healthy Volunteers With Elevated Lipoprotein(a)

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-02-29

Brief Summary

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The purpose is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of IONIS APO(a)-LRx (ISIS 681257) given to healthy volunteer subjects.

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Detailed Description

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Conditions

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Elevated Lipoprotein(a)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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IONIS-APO(a)-LRx

Drug: IONIS-APO(a)-LRx

Group Type EXPERIMENTAL

IONIS-APO(a)-LRx

Intervention Type DRUG

Ascending single and multiple doses of IONIS-APO(a)-LRx by subcutaneous (SC) injection

Placebo (Normal Saline)

Drug: Sterile Normal Saline (0.9% NaCl)

Group Type PLACEBO_COMPARATOR

Sterile Normal Saline (0.9% NaCl)

Intervention Type DRUG

Calculated volume to match active comparator

Interventions

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IONIS-APO(a)-LRx

Ascending single and multiple doses of IONIS-APO(a)-LRx by subcutaneous (SC) injection

Intervention Type DRUG

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 and weighing ≥ 50 kg at the time of informed consent
* 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 Lp(a) ≥ 75 nanomoles/liter nmol/L (30 mg/dL) at Screening

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 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