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

• Status: Recruiting
• Trial end date: 2022-11-12
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Amgen

Criteria

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