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NCT04189484 · ClinicalTrials.gov registry record · Phase 1
Pharmacodynamic Biomarkers to Support Biosimilar Development: PCSK9 Inhibitors
A Phase 1 study, sponsored by Food and Drug Administration (FDA).
- Completed
- Registry status
- Phase 1
- Development phase
- 72
- Enrollment target
NCT04189484 is a Phase 1 study that has completed, run by Food and Drug Administration (FDA). The registered enrollment target is 72 participants.
The verdict
NCT04189484, a Phase 1 study, has completed, sponsored by Food and Drug Administration (FDA).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 72 participants
- Enrollment target
Study Summary
This study is designed to assess pharmacokinetics and pharmacodynamics of evolocumab and alirocumab across an appropriate dose range to inform clinical trial operating characteristics for future clinical pharmacology pharmacodynamics similarity studies. This is a randomized, placebo-controlled, single-dose, parallel arm study in 72 healthy subjects assigned to one of four dose groups (low, intermediate low, intermediate high, and high) of each drug (evolocumab and alirocumab ) or placebo.
Interventions
- BIOLOGICAL Evolocumab
- BIOLOGICAL Alirocumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2020-01-07 |
| Est. Completion | 2021-04-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04189484
The ClinicalTrials.gov registry entry for NCT04189484 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Food and Drug Administration (FDA), which has 23 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Evolocumab is the first listed.
NCT04189484 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04189484 about?
NCT04189484 is a clinical study titled "Pharmacodynamic Biomarkers to Support Biosimilar Development: PCSK9 Inhibitors". This study is designed to assess pharmacokinetics and pharmacodynamics of evolocumab and alirocumab across an appropriate dose range to inform clinical trial operating characteristics for future clinical pharmacology pharmacodynamics similarity studies. This is a randomized, placebo-controlled, sin...
What is the current status of trial NCT04189484?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 72 participants. The study started on 2020-01-07. Estimated completion is 2021-04-07.
What interventions are being tested in trial NCT04189484?
The interventions under investigation include: Evolocumab (BIOLOGICAL), Alirocumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04189484?
This trial is sponsored by Food and Drug Administration (FDA), which has 23 total clinical trials registered on ClinicalTrials.gov.
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