A Phase 1 Randomized Double-blind Placebo-controlled Single Ascending Dose Study to Evaluate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of AMG 890 in Subjects With Elevated Plasma Lipoprotein(a

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Cardiovascular Disease
    Elevated Plazma Lipopr0tein
  • Age: Between 18 - 60 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Subjects with ages between 18 and 60 years old, inclusive, for cohorts 1 to 5; and with ages between 18 and 65 years old, inclusive, for cohorts 6 and 7.
    2. Subjects with Plasma Lp(a):
      • = 70 nmol/L and = 199 nmol/L for cohorts 1 to 5
      • = 200 nmol/L for cohorts 6 and 7
    3. For cohorts 6 and 7, subjects who are on statin must be on a stable dose of the same statin for at least 6 weeks prior to enrollment, and plan to remain on a stable dose for the duration of the study
    4. Women must be of non-reproductive potential
    5. Men must agree to practice an acceptable method of effective birth control while on study or for 90 days after receiving investigational product
    6. Men must be willing to abstain from sperm donation while on study or for 90 days after receiving investigational product

You may not be eligible for this study if the following are true:

    1. Subjects currently receiving treatment in another investigational device or drug study, or less than 30 days or 5 half-lives (whichever is longer), since ending treatment on another investigational device or drug study(s) prior to receiving the first dose of investigational product
    2. Subjects breastfeeding or plan to breastfeed while on the study
    3. Men with partners who are pregnant or planning to become pregnant while the subject is on study or through 90 days after receiving investigational product.
    4. Subjects are pregnant
    5. Subjects with history or evidence of a clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
    6. Subjects who planned elective surgery to occur at any time
    7. Subjects with history of peripheral neuropathy
    8. Subjects with history of malignancy of any type
    9. Subjects with positive results for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C virus ribonucleic acid (RNA)
    10. Subjects previously enrolled in this study or has been previously exposed to AMG 890
    11. Subjects who use of any herbal medicines, vitamins or supplements known to affect lipid metabolism
    12. All herbal supplements, vitamins, and nutritional supplements taken within 30 days
    13. Subjects with history of substance abuse, use of nicotine, or alcohol
    14. Subjects who will not be available for protocol-required study visits or procedures, to the best of the subject’s and investigator’s knowledge
    15. Any other condition that might reduce the chance of obtaining data required by the protocol or that might compromise the ability to give informed consent



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