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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: Completed Phase 1 study, sponsored by Food and Drug Administration (FDA).
NCT04189484 is a Phase 1 study that has completed, run by Food and Drug Administration (FDA). The registered enrollment target is 72 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The values and variability of AUEC for LDL-C at low, intermediate-low, intermediate-high, and high doses of evolocumab and alirocumab. AUEC was calculated as the baseline-subtracted area under the LDL-C concentration-time curve expressed in units of mg/(dL\*day). More negative AUEC values represent greater reductions in LDL-C exposure from baseline. The standard deviation is noted in parentheses. For each subject and dose, the maximum decrease from baseline LDL-C was determined using all sampled
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 |
What the finished NCT04189484 record still lists
NCT04189484 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% higher).
The record links to 0 conditions, and to 2 interventions - of which Evolocumab is the first listed.
NCT04189484 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04189484's enrollment target sits among peer trials
72 736th of 2000 higher than 1,254 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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