Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of AMG 890 in Subjects With Ele… (NCT03626662) | Clinical Trial Compass
CompletedPhase 1
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of AMG 890 in Subjects With Elevated Plasma Lipoprotein(a)
United States79 participantsStarted 2018-07-30
Plain-language summary
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.
Who can participate
Age range18 Years – 70 Years
SexALL
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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
What they're measuring
1
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
Timeframe: From first dose of trial until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months