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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: Completed Phase 1 study of Healthy Volunteers, sponsored by CSL Behring.
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. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT04580654 record still lists
NCT04580654 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (92% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Healthy Volunteers
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04580654's enrollment target sits among peer trials
38 164th of 283 higher than 120 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers 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.
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