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NCT04183491 · ClinicalTrials.gov registry record · Phase 1
Pharmacodynamic Biomarkers to Support Biosimilar Development: Interferon Beta-1A Products
A Phase 1 study, sponsored by Food and Drug Administration (FDA).
- Completed
- Registry status
- Phase 1
- Development phase
- 84
- Enrollment target
NCT04183491: Completed Phase 1 study, sponsored by Food and Drug Administration (FDA).
NCT04183491 is a Phase 1 study that has completed, run by Food and Drug Administration (FDA). The registered enrollment target is 84 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04183491, a Phase 1 study, has completed, sponsored by Food and Drug Administration (FDA).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 84 participants
- Enrollment target
Study Summary
This study is designed to assess pharmacokinetics and pharmacodynamics of interferon beta-1a and peginterferon beta-1a 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 84 healthy subjects assigned to one of three dose groups (low, intermediate, and high) of each drug (interferon beta-1a and peginterferon beta-1a) or placebo.
Primary Outcome
The values and variability of standard pharmacodynamic (PD) metric (AUEC \[baseline subtracted\]) for neopterin at low, intermediate, and high doses of interferon beta-1a and peginterferon beta-1a
Interventions
- BIOLOGICAL Interferon beta-1a
- BIOLOGICAL Peginterferon beta-1a
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2020-02-28 |
| Est. Completion | 2021-01-26 |
| Phase | Phase 1 |
What the finished NCT04183491 record still lists
NCT04183491 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% higher).
The record links to 0 conditions, and to 2 interventions - of which Interferon beta-1a is the first listed.
NCT04183491 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04183491 about?
NCT04183491 is a clinical study titled "Pharmacodynamic Biomarkers to Support Biosimilar Development: Interferon Beta-1A Products". This study is designed to assess pharmacokinetics and pharmacodynamics of interferon beta-1a and peginterferon beta-1a across an appropriate dose range to inform clinical trial operating characteristics for future clinical pharmacology pharmacodynamics similarity studies. This is a randomized, plac...
What is the current status of trial NCT04183491?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 84 participants. The study started on 2020-02-28. Estimated completion is 2021-01-26.
What interventions are being tested in trial NCT04183491?
The interventions under investigation include: Interferon beta-1a (BIOLOGICAL), Peginterferon beta-1a (BIOLOGICAL).
Who is sponsoring clinical trial NCT04183491?
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 NCT04183491's enrollment target sits among peer trials
84 659th of 2000 higher than 1,336 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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