RecruitingPhase 1

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

United States400 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.

Age range18 Years – 60 Years

SexALL

See this in plain English?

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

✓. 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.

✕. 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.
✕. Have previously completed or withdrawn from this trial or any other trial investigating evolocumab, any other product directed against PCSK9, or have previously received evolocumab or PCSK9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.

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

NCT IDNCT07422285

SponsorAmgen

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06-30

Amgen Call Center

Who can participate

Age range18 Years – 60 Years

SexALL

See this in plain English?

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

✓. 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.

✕. 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.
✕. 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.

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