Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of AMG 890 in Subjects With Elevated Plasma Lipoprotein(a)

Amgen logo

Amgen

Status and phase

Completed
Phase 1

Conditions

Cardiovascular Disease

Treatments

Drug: Placebo
Drug: AMG 890

Study type

Interventional

Funder types

Industry

Identifiers

NCT03626662
20170544

Details and patient eligibility

About

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.

Enrollment

79 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

79 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Single Ascending Dose Cohorts
Treatment:
Drug: Placebo
AMG 890
Experimental group
Description:
Single Ascending Dose Cohorts
Treatment:
Drug: AMG 890

Trial contacts and locations

9

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems