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Study identifier: NCT07545226 Synced from ClinicalTrials.gov · August 07, 2026
● Study status: Active Not Recruiting

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

Condition: Healthy Participants  ·  Sponsor: Amgen

PhasePhase 1
Planned participants405
Who can joinAll sexes, 18 Years to 60 Years
Healthy volunteersYesCheck eligibility criteria ↓
Where4 locations

Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.

About this study

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

This description comes directly from the study's public registry record.

Talk to the study team

No contact information is available for this study as per the public registry record.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

Inclusion Criteria: 1. Male or female, of any race, between 18 and 60 years of age, inclusive. a. Females must not be pregnant or lactating. 2. Body mass index (BMI) between 18.0 and 32.0 kg/m\^2 inclusive. 3. LDL-C level ≥ 70 mg/dL (1.8 mmol/L) and ≤ 190 mg/dL (4.9 mmol/L) at screening. Exclusion Criteria: 1. 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. 2. History or current signs or symptoms of cardiovascular disease. 3. History or evidence of clinically significant arrhythmia. 4. History of hypersensitivity, intolerance, or allergy to evolocumab or its ingredients or other biological drugs. 5. Uncontrolled hyperthyroidism or hypothyroidism. 6. Current use or prior use of over-the-counter or other prescription medications, herbal medicines, vitamins, and supplements within 30 days or 5 half-lives prior to check-in. 7. Participation in another investigational device or drug trial within the past 30 days or 5 half-lives prior to check-in. 8. Have previously completed or withdrawn from this trial or any other trial investigating evolocumab, any other product directed against PCSK9, or have previously received evolocumab or PCSK9 inhibitor.

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (4)

Anaheim Clinical TrialsAnaheim, California, United States
Quest Pharmaceutical Services - Miami Research Associates - Early PhaseSouth Miami, Florida, United States
QPS Bio-KineticSpringfield, Missouri, United States
Fortrea Clinical Research Unit - DallasDallas, Texas, United States

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