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NCT01500408 · ClinicalTrials.gov registry record · Phase 1
Demonstrate the Bioequivalence of Interferon Beta-1a (INFB) Manufactured by Two Different Processes in Healthy Volunteers
A Phase 1 study of Multiple Sclerosis, sponsored by Biogen.
- Completed
- Registry status
- Phase 1
- Development phase
- 110
- Enrollment target
- 1
- Study location
NCT01500408 is a Phase 1 study of Multiple Sclerosis that has completed, run by Biogen. The registered enrollment target is 110 participants, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01500408, a Phase 1 study of Multiple Sclerosis, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 110 participants
- Enrollment target
- 1
- Study location
Study Summary
Biogen Idec has developed a novel process to manufacture Interferon beta-1a (INFB), the active ingredient of Avonex®, that does not include fetal bovine serum (FBS). This bioequivalence study is being conducted to confirm the pharmacokinetic (PK) and pharmacodynamic (PD) comparability of Interferon beta-1a produced by the currently approved serum-containing process and Interferon beta-1a produced by the new serum-free manufacturing process.
Conditions Studied
Interventions
- DRUG Interferon beta-1a (current approved manufacturing process invloving FBS)
- DRUG Interferon beta-1a (new process, manufactured without FBS)
Study Locations (1)
Minnesota
- Research Site - Saint Paul
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2012-01 |
| Est. Completion | 2012-04 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01500408
The ClinicalTrials.gov registry entry for NCT01500408 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 110 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (81% lower). The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Multiple Sclerosis appearing as the primary indexed condition, and to 2 interventions - of which Interferon beta-1a (current approved manufacturing process invloving FBS) is the first listed.
NCT01500408 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.
Frequently Asked Questions
What is clinical trial NCT01500408 about?
NCT01500408 is a clinical study titled "Demonstrate the Bioequivalence of Interferon Beta-1a (INFB) Manufactured by Two Different Processes in Healthy Volunteers". Biogen Idec has developed a novel process to manufacture Interferon beta-1a (INFB), the active ingredient of Avonex®, that does not include fetal bovine serum (FBS). This bioequivalence study is being conducted to confirm the pharmacokinetic (PK) and pharmacodynamic (PD) comparability of Interferon ...
What is the current status of trial NCT01500408?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 110 participants. The study started on 2012-01. Estimated completion is 2012-04.
What conditions does trial NCT01500408 study?
This clinical trial studies the following conditions: Multiple Sclerosis.
What interventions are being tested in trial NCT01500408?
The interventions under investigation include: Interferon beta-1a (current approved manufacturing process invloving FBS) (DRUG), Interferon beta-1a (new process, manufactured without FBS) (DRUG).
Who is sponsoring clinical trial NCT01500408?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01500408 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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