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CompletedNCT07545226Updated Oct 2, 2026

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

A Phase 1 interventional study of Evolocumab Drug Substance A (Test) and Evolocumab Drug Substance B (Reference) in Healthy Participants, sponsored by Amgen. Completed at 4 sites in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-02.

Sponsored by Amgen · Phase 1, Interventional, and Basic science

Updated Oct 2, 2026Now CompletedPrimary completion moved+1 moreGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
405
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Healthy Participants

Keywords

  • Evolocumab
  • AMG 145
  • Pharmacokinetics
03

In context

Lead sponsor

Amgen is the lead sponsor of 1,015 studies on the registry; 49 are open to participants now.

Of its 245 completed or terminated interventional studies of FDA-regulated products, 159 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
405 participants (actual)

Study arms

  • Experimental
    Evolocumab Drug Substance A (Test)

    Participants will receive a single subcutaneous (SC) dose of evolocumab drug substance A.

    Drug: Evolocumab Drug Substance A (Test)

  • Experimental
    Evolocumab Drug Substance B (Reference)

    Participants will receive a single SC dose of evolocumab drug substance B.

    Drug: Evolocumab Drug Substance B (Reference)

Interventions

  • DrugEvolocumab Drug Substance A (Test)

    Evolocumab drug substance A will be administered SC.

    Also known as: AMG 145

  • DrugEvolocumab Drug Substance B (Reference)

    Evolocumab drug substance B will be administered SC.

    Also known as: AMG 145

06

What researchers measure

Primary outcomes

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

    Time frame: Day 1 to Day 64

  2. AUC from Time 0 to Time of Last Quantifiable Concentration (AUClast) of Evolocumab

    Time frame: Day 1 to Day 64

  3. Maximum Observed Concentration (Cmax) of Evolocumab

    Time frame: Day 1 to Day 64

Secondary outcomes

  1. Number of Participants with Treatment-emergent Adverse Events (TEAEs)

    Time frame: Day 1 to Day 64

  2. Number of Participants with Serious Adverse Events (SAEs)

    Time frame: Up to Day 64

  3. Number of Participants with Anti-evolocumab Antibody Formation

    Time frame: Day 1 and Day 64

  4. Area Under the Effect Curve From Day 1 through Day 64 (AUECDay1-Day64) of Low-density Lipoprotein Cholesterol (LDL-C)

    Time frame: Day 1 to Day 64

  5. Serum Levels of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)

    Time frame: Day 1 to Day 64

07

Study locations

4 sites
  • Anaheim Clinical Trials
    Anaheim, California 92801-2658, United States
  • Quest Pharmaceutical Services - Miami Research Associates - Early Phase
    South Miami, Florida 33143, United States
  • QPS Bio-Kinetic
    Springfield, Missouri 65802, United States
  • Fortrea Clinical Research Unit - Dallas
    Dallas, Texas 75247, United States
08

References and documents

Individual participant data

Plan to share: Yes — De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Supporting information: Study protocol, Sap, Icf, Csr

09

Updates

1 registry update since Sep 25, 2026
Status
Active, not recruiting→Completed
changed Oct 2, 2026
Primary completion
Sep 3, 2026→Sep 2, 2026 (actual)
Oct 2, 2026
Study completion
Sep 3, 2026→Sep 8, 2026 (actual)
Oct 2, 2026
Show all 1 update
  1. Oct 2, 2026
    Active, not recruiting→Completed
    Primary completion Sep 3, 2026→Sep 2, 2026 (now actual)
    Study completion Sep 3, 2026→Sep 8, 2026 (now actual)
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07545226
Lead sponsor
Amgen
Responsible party
Sponsor
First posted
Apr 22, 2026
Start date
Apr 21, 2026
Primary completion
Sep 2, 2026
Completion
Sep 8, 2026
Last update
Oct 2, 2026

Study contacts

MD
study director · Amgen

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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