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

NCT07545226 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2026-04-22

No results posted yet for this study

Summary

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

Conditions

  • Healthy Participants

Interventions

DRUG

Evolocumab Drug Substance A (Test)

Evolocumab drug substance A will be administered SC.

DRUG

Evolocumab Drug Substance B (Reference)

Evolocumab drug substance B will be administered SC.

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-20
Primary Completion
2026-09-08
Completion
2026-09-08
FDA Drug
Yes

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07545226 on ClinicalTrials.gov