Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of AMG 890 in Subjects With Elevated Plasma Lipoprotein(a)
Completed · Phase 1 · Has a placebo group
Conditions studied: Cardiovascular Disease
In brief
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.
Key facts
- Study ID
- NCT03626662
- Run by
- Amgen
- People needed
- 79
- Starts
- 2018-07-30
- Expected to finish
- 2023-04-18
- Last updated by the study team
- 2026-01-28
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Orange County Research Center — Tustin, California, United States
- Excel Medical Clinical Trials — Boca Raton, Florida, United States
- Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
- QPS Miami Research Associates — South Miami, Florida, United States
- University of Kansas Medical Center — Kansas City, Kansas, United States
- New York University — New York, New York, United States
- Medpace Inc — Cincinnati, Ohio, United States
- Clinical Medical and Analytical eXellence CMAX — Adelaide, South Australia, Australia
- Linear Clinical Research Limited — Nedlands, Western Australia, Australia
Full record on ClinicalTrials.gov
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