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Purpose

This is a first-in-human, randomized, double-blind, placebo-controlled, single ascending dose study in subjects with elevated plasma Lipoprotein(a) [Lp(a)]. AMG 890 will be evaluated in approximately 80 subjects to assess safety, tolerability, pharmacokinetics and pharmacodynamic effects.

Condition

Eligibility

Eligible Ages
Between 18 Years and 70 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Men and women with ages between 18 and 70 years old, inclusive. - Protocol-defined elevated plasma Lp(a) level. - Body mass index (BMI) greater than or equal to 18 and less than or equal to 40 kg/m2, at screening. - Women must be of non-reproductive potential. - Other Inclusion criteria may apply

Exclusion Criteria

  • Currently receiving treatment in another investigational device or drug study. - Women who are lactating/breastfeeding or who plan to breastfeed while on study or through 90 days after receiving the last dose of investigational product (for subjects who withdraw prior to end of study). - 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. - History or clinical evidence of bleeding diathesis or any coagulation disorder. - History or clinical evidence of peripheral neuropathy. - Other Exclusion criteria may apply

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Other
Masking
Triple (Participant, Care Provider, Investigator)
Masking Description
The subjects and the investigative site staff, except for the unblinded pharmacist, will be blinded to treatment assignment.

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Placebo 		Single Ascending Dose Cohorts
  • Drug: Placebo
    Calculated volume to match experimental drug.
Experimental
AMG 890 		Single Ascending Dose Cohorts
  • Drug: AMG 890
    Ascending Single Doses of AMG 890

More Details

Status
Completed
Sponsor
Amgen

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.