Comparing the Extent to Which Two Evolocumab Drug Products Are Made Available in the Body After a Single Subcutaneous Dose.

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorAmgen

About this trial

The primary objective of this trial is to evaluate the pharmacokinetics (PK) of two evolocumab drug products in healthy participants.

Eligibility criteria

Qualifiers

Male or female, of any race, between 18 and 60 years of age, inclusive.

Body mass index (BMI) between 18.0 and 32.0 kg/m² inclusive.

LDL-C level ≥ 70 mg/dL (1.8 mmol/L) and ≤ 190 mg/dL (4.9 mmol/L) at screening.

Disqualifiers

History or evidence of any clinically significant disorder, condition, or disease that in the opinion of the investigator (or designee) would pose a risk to participant safety or interfere with the trial evaluation, procedures, or completion.

History or current signs or symptoms of cardiovascular disease.

History or evidence of clinically significant arrhythmia.

History of hypersensitivity, intolerance, or allergy to evolocumab or its ingredients or other biological drugs.

Trial design

Treatments tested in this trial

  • Evolocumab Drug Substance A (Test)
  • Evolocumab Drug Substance B (Reference)

Treatment groups

400 Participants
are divided into 2 treatment groups

Sponsors and collaborators