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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 is a Phase 1 study that has completed, run by Food and Drug Administration (FDA). The registered enrollment target is 84 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04183491
The ClinicalTrials.gov registry entry for NCT04183491 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 84 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 Interferon beta-1a is the first listed.
NCT04183491 reports 0 study locations.
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.
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