Healthy ParticipantsPhase 1NCT07422285
Comparing the Extent to Which Two Evolocumab Drug Products Are Made Available in the Body After a Single Subcutaneous Dose
A Phase 1 study testing Evolocumab Drug Substance A and Evolocumab Drug Substance B in people with Healthy Participants and Pharmacokinetics, run by Amgen at 4 sites in United States.
Trial summary
The main objective of this trial is to evaluate the pharmacokinetics of two evolocumab drug products in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants, Pharmacokinetics
- What is being tested?
- Evolocumab Drug Substance A and Evolocumab Drug Substance B
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 405 participants
- Where
- 4 sitesUnited States
- Study dates
- 16 Jan 2026to 24 Jul 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female, of any race, between 18 and 60 years of age, inclusive.
- Females must not be pregnant or lactating.
- 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.
Who cannot join
- 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- Have previously completed or withdrawn from this trial or any other trial investigating evolocumab, any other product directed against PCSK9, or have previously received evolocumab or PCSK9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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Ohio Clinical Trials, Inc.
Columbus, Ohio, 43212
Fortrea Clinical Research Unit - Dallas
Dallas, Texas, 75247
Fortrea Clinical Research Unit Inc. - Madison
Madison, Wisconsin, 53704-2526
QPS Bio-Kinetic
Springfield, Missouri, 65802-4842
About this study
Official title: An Open-label, Phase 1, Single Dose, Randomized, Parallel-group Study to Evaluate the Relative Bioavailability of Two Evolocumab (AMG 145) Drug Products
The main objective of this trial is to evaluate the pharmacokinetics of two evolocumab drug products in healthy participants.
- Conditions
- Healthy Participants, Pharmacokinetics
- Being tested
- Evolocumab Drug Substance A, Evolocumab Drug Substance B
- Keywords
- Evolocumab, AMG 145
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evolocumab Drug Substance ADrug
Also called AMG 145
Evolocumab drug substance A will be administered SC.
Evolocumab Drug Substance BDrug
Also called AMG 145
Evolocumab drug substance B will be administered SC.
| Study group | Role | What they receive |
|---|---|---|
| Evolocumab Drug Substance A | Experimental | Participants will receive a single subcutaneous (SC) dose of evolocumab drug substance A. Receives: Drug: Evolocumab Drug Substance A |
| Evolocumab Drug Substance B | Experimental | Participants will receive a single SC dose of evolocumab drug substance B. Receives: Drug: Evolocumab Drug Substance B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Concentration-time Curve (AUC) from Time 0 Extrapolated to Infinity (AUCinf) of Evolocumab
Measured: Day 1 to Day 64
Area Under the Concentration-time Curve from Time 0 to Time of Last Quantifiable Concentration (AUClast) of Evolocumab
Measured: Day 1 to Day 64
Maximum Observed Concentration (Cmax) of Evolocumab
Measured: Day 1 to Day 64
Secondary outcomes (5)
Number of Participants with Treatment-emergent Adverse Events
Measured: Day 1 to Day 64
Number of Participants with Serious Adverse Events
Measured: Up to Day 64
Number of Participants with Anti-evolocumab Antibody Formation
Measured: Day 1 and Day 64
Area Under the Effect Curve From Day 1 through Day 64 (AUECDay1-Day64) of Low-density Lipoprotein Cholesterol (LDL-C)
Measured: Day 1 to Day 64
Serum Levels of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)
Measured: Day 1 to Day 64
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start16 Jan 2026
- Primary completion24 Jul 2026
- Study completion24 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 405 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07422285
- Sponsor's protocol ID
- 20240180
- Status last verified
- Aug 2026
- First submitted
- 12 Feb 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Phase 1, Single Dose, Randomized, Parallel-group Study to Evaluate the Relative Bioavailability of Two Evolocumab (AMG 145) Drug Products
- ClinicalTrials.gov ID
- NCT07422285
- Acronym / sponsor ID
- 20240180
- Conditions
- Healthy Participants, Pharmacokinetics
- Keywords
- Evolocumab, AMG 145
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 405 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 16 Jan 2026 (actual)
- Primary completion
- 24 Jul 2026 (actual)
- Study completion
- 24 Jul 2026 (actual)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this trial is to evaluate the pharmacokinetics of two evolocumab drug products in healthy participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Evolocumab Drug Substance A | Experimental | Drug: Evolocumab Drug Substance AParticipants will receive a single subcutaneous (SC) dose of evolocumab drug substance A. |
| Evolocumab Drug Substance B | Experimental | Drug: Evolocumab Drug Substance BParticipants will receive a single SC dose of evolocumab drug substance B. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evolocumab Drug Substance AAlso: AMG 145Evolocumab drug substance A will be administered SC. | Drug | Evolocumab Drug Substance A |
| Evolocumab Drug Substance BAlso: AMG 145Evolocumab drug substance B will be administered SC. | Drug | Evolocumab Drug Substance B |
Primary outcome
Area Under the Concentration-time Curve (AUC) from Time 0 Extrapolated to Infinity (AUCinf) of Evolocumab
Time frame: Day 1 to Day 64
Area Under the Concentration-time Curve from Time 0 to Time of Last Quantifiable Concentration (AUClast) of Evolocumab
Time frame: Day 1 to Day 64
Maximum Observed Concentration (Cmax) of Evolocumab
Time frame: Day 1 to Day 64
5 secondary outcomes
Number of Participants with Treatment-emergent Adverse Events
Time frame: Day 1 to Day 64
Number of Participants with Serious Adverse Events
Time frame: Up to Day 64
Number of Participants with Anti-evolocumab Antibody Formation
Time frame: Day 1 and Day 64
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
Serum Levels of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)
Time frame: Day 1 to Day 64
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Evolocumab Drug Substance A and Evolocumab Drug Substance B in people with Healthy Participants and Pharmacokinetics, run by Amgen at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Concentration-time Curve (AUC) from Time 0 Extrapolated to Infinity (AUCinf) of Evolocumab (time frame: Day 1 to Day 64). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.