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NCT04571424 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB133 (Dapirolizumab Pegol) in Healthy Japanese and Caucasian Participants
A Phase 1 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
NCT04571424 is a Phase 1 study that has completed, run by Biogen. The registered enrollment target is 33 participants.
The verdict
NCT04571424, a Phase 1 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
Study Summary
The primary objective of the study is to assess the safety and tolerability of a single intravenous (IV) dose of dapirolizumab pegol (DZP) in Japanese healthy study participants compared with those of Caucasian healthy study participants. The secondary objectives of the study are to assess the pharmacokinetic(s) (PK) of a single IV dose of DZP in Japanese and Caucasian healthy study participants, to evaluate ethnic sensitivity on the PK of DZP between body weight- and gender-matched Japanese and Caucasian healthy study participants and to evaluate the immunogenicity of a single IV dose of DZP in Japanese and Caucasian healthy study participants.
Interventions
- DRUG Placebo
- DRUG BIIB133 (Dapirolizumab pegol)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2020-10-14 |
| Est. Completion | 2021-04-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04571424
The ClinicalTrials.gov registry entry for NCT04571424 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04571424 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04571424 about?
NCT04571424 is a clinical study titled "A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB133 (Dapirolizumab Pegol) in Healthy Japanese and Caucasian Participants". The primary objective of the study is to assess the safety and tolerability of a single intravenous (IV) dose of dapirolizumab pegol (DZP) in Japanese healthy study participants compared with those of Caucasian healthy study participants. The secondary objectives of the study are to assess the phar...
What is the current status of trial NCT04571424?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2020-10-14. Estimated completion is 2021-04-08.
What interventions are being tested in trial NCT04571424?
The interventions under investigation include: Placebo (DRUG), BIIB133 (Dapirolizumab pegol) (DRUG).
Who is sponsoring clinical trial NCT04571424?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
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