Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of AMG 890 in Subjects With Elevated Plasma Lipoprotein(a)
Status: | Recruiting |
---|---|
Conditions: | Peripheral Vascular Disease |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 3/13/2019 |
Start Date: | July 30, 2018 |
End Date: | August 31, 2020 |
Contact: | Amgen Call Center |
Email: | medinfo@amgen.com |
Phone: | 866-572-6436 |
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)
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 64 subjects to assess safety, tolerability, pharmacokinetics and
pharmacodynamic effects.
study in subjects with elevated plasma Lipoprotein(a) [Lp(a)]. AMG 890 will be evaluated in
approximately 64 subjects to assess safety, tolerability, pharmacokinetics and
pharmacodynamic effects.
Inclusion Criteria:
- Men and women with ages between 18 and 65 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 32 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
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