Active — Not RecruitingPhase 1

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

United States405 participantsStarted 2026-01-16

Plain-language summary

The main objective of this trial is to evaluate the pharmacokinetics of two evolocumab drug products in healthy participants.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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/m\^2 inclusive.
. LDL-C level ≥ 70 mg/dL (1.8 mmol/L) and ≤ 190 mg/dL (4.9 mmol/L) at screening.

Exclusion criteria

. 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.
. Uncontrolled hyperthyroidism or hypothyroidism.
. 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.
. Participation in another investigational device or drug trial within the past 30 days or 5 half-lives prior to check-in.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Area Under the Concentration-time Curve (AUC) from Time 0 Extrapolated to Infinity (AUCinf) of Evolocumab

Timeframe: Day 1 to Day 64

Area Under the Concentration-time Curve from Time 0 to Time of Last Quantifiable Concentration (AUClast) of Evolocumab

Timeframe: Day 1 to Day 64

Maximum Observed Concentration (Cmax) of Evolocumab

Timeframe: Day 1 to Day 64

Trial details

NCT IDNCT07422285

SponsorAmgen

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-07-24

View on ClinicalTrials.gov More Healthy Participants trials

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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/m\^2 inclusive.
. LDL-C level ≥ 70 mg/dL (1.8 mmol/L) and ≤ 190 mg/dL (4.9 mmol/L) at screening.

Exclusion criteria

. 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.
. Uncontrolled hyperthyroidism or hypothyroidism.
. 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.
. Participation in another investigational device or drug trial within the past 30 days or 5 half-lives prior to check-in.

What they're measuring

Area Under the Concentration-time Curve (AUC) from Time 0 Extrapolated to Infinity (AUCinf) of Evolocumab

Timeframe: Day 1 to Day 64

Area Under the Concentration-time Curve from Time 0 to Time of Last Quantifiable Concentration (AUClast) of Evolocumab

Timeframe: Day 1 to Day 64

Maximum Observed Concentration (Cmax) of Evolocumab

Timeframe: Day 1 to Day 64