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NCT04580654 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Pharmacokinetics and Safety of CSL312 in Healthy Japanese and Caucasian Adults
A Phase 1 study of Healthy Volunteers, sponsored by CSL Behring.
- Completed
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
- 1
- Study location
NCT04580654 is a Phase 1 study of Healthy Volunteers that has completed, run by CSL Behring. The registered enrollment target is 38 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04580654, a Phase 1 study of Healthy Volunteers, has completed, sponsored by CSL Behring.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 38 participants
- Enrollment target
- 1
- Study location
Study Summary
This will be a 2- part, phase 1, open-label, single center, single ascending dose study to investigate the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of subcutaneous (SC) and intravenous (IV) administration of CSL312 in healthy adult Japanese and Caucasian subjects.
Conditions Studied
Interventions
- BIOLOGICAL CSL312
Study Locations (1)
California
- Anaheim Clinical Trials, LLC - Anaheim
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2020-10-29 |
| Est. Completion | 2021-05-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04580654
The ClinicalTrials.gov registry entry for NCT04580654 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (92% lower). The listed sponsor is CSL Behring, which has 71 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 1 intervention - of which CSL312 is the first listed.
NCT04580654 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT04580654 about?
NCT04580654 is a clinical study titled "A Study to Assess the Pharmacokinetics and Safety of CSL312 in Healthy Japanese and Caucasian Adults". This will be a 2- part, phase 1, open-label, single center, single ascending dose study to investigate the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of subcutaneous (SC) and intravenous (IV) administration of CSL312 in healthy adult Japanese and Caucasian subjects.
What is the current status of trial NCT04580654?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2020-10-29. Estimated completion is 2021-05-07.
What conditions does trial NCT04580654 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT04580654?
The interventions under investigation include: CSL312 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04580654?
This trial is sponsored by CSL Behring, which has 71 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04580654 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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