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

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NCT07545226 · readout in 15 d

Sponsored by Amgen (industry) · AMGN — their whole pipeline →.

Phase

Phase 1

Status

Active, not recruiting

Study type

Interventional

Design

Randomized · None · Basic science

Enrollment

405actual

Sites

Country

United States

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2026-04-21

actual

When the study began enrolling

Primary completion

2026-09-03

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

2026-09-03

estimated

The whole study's end, after follow-up

First posted

2026-04-22

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-07-20

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

Healthy Participants

Interventions

Drug: Evolocumab Drug Substance A (Test) — also filed as AMG 145
Drug: Evolocumab Drug Substance B (Reference) — also filed as AMG 145

Primary outcomes

what the primary-completion date above is the date OF

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

measured Day 1 to Day 64

AUC 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

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