Comparing the Extent to Which Two Evolocumab Drug Products Are Made Available in the Body After a Single Subcutaneous Dose
NCT07422285 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 400
Last updated 2026-04-16
Summary
The main objective of this trial is to evaluate the pharmacokinetics of two evolocumab drug products in healthy participants.
Conditions
- Healthy Participants
- Pharmacokinetics
Interventions
- DRUG
-
Evolocumab Drug Substance A
Evolocumab drug substance A will be administered SC.
- DRUG
-
Evolocumab Drug Substance B
Evolocumab drug substance B will be administered SC.
Sponsors & Collaborators
- lead INDUSTRY
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
- 2026-01-16
- Primary Completion
- 2026-06-30
- Completion
- 2026-06-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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