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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.

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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

FieldValue
Enrollment Target 38 participants
Start Date 2020-10-29
Est. Completion 2021-05-07
Phase Phase 1

Sponsor

CSL Behring

71 total trials

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.