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

Ionis Pharmaceuticals logo

Ionis Pharmaceuticals

Status and phase

Completed
Phase 1

Conditions

Elevated Lipoprotein(a)

Treatments

Drug: Sterile Normal Saline (0.9% NaCl)
Drug: IONIS-APO(a)-LRx

Study type

Interventional

Funder types

Industry

Identifiers

NCT02414594
IONIS-APO(a)-LRx

Details and patient eligibility

About

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

Enrollment

60 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 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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Double Blind

60 participants in 2 patient groups, including a placebo group

IONIS-APO(a)-LRx
Experimental group
Description:
Drug: IONIS-APO(a)-LRx
Treatment:
Drug: IONIS-APO(a)-LRx
Placebo (Normal Saline)
Placebo Comparator group
Description:
Drug: Sterile Normal Saline (0.9% NaCl)
Treatment:
Drug: Sterile Normal Saline (0.9% NaCl)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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