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NCT04578535 · ClinicalTrials.gov registry record · Phase 1

A Study to Assess the Tolerability, Safety, and Pharmacokinetics of Subcutaneous Immune Globulin Infusion 10% (Human) With Recombinant Human Hyaluronidase (HYQVIA/HyQvia) With Ramp-up and No Ramp-up Dosing in Healthy Adult Participants

A Phase 1 study, sponsored by Baxalta now part of Shire.

Completed
Registry status
Phase 1
Development phase
51
Enrollment target

NCT04578535 is a Phase 1 study that has completed, run by Baxalta now part of Shire. The registered enrollment target is 51 participants.

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The verdict

NCT04578535, a Phase 1 study, has completed, sponsored by Baxalta now part of Shire.

COMPLETED
Registry status
Phase 1
Development phase
51 participants
Enrollment target

Study Summary

The purpose of the study is to assess the tolerability, safety, and pharmacokinetics of HYQVIA with ramp-up and no ramp-up dosing in healthy adult participants.

Interventions

  • DRUG HYQVIA

Trial Details

FieldValue
Enrollment Target 51 participants
Start Date 2020-10-27
Est. Completion 2022-03-02
Phase Phase 1

Sponsor

Baxalta now part of Shire

74 total trials

What the Registry Record Tells You About NCT04578535

The ClinicalTrials.gov registry entry for NCT04578535 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baxalta now part of Shire, which has 74 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which HYQVIA is the first listed.

NCT04578535 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04578535 about?

NCT04578535 is a clinical study titled "A Study to Assess the Tolerability, Safety, and Pharmacokinetics of Subcutaneous Immune Globulin Infusion 10% (Human) With Recombinant Human Hyaluronidase (HYQVIA/HyQvia) With Ramp-up and No Ramp-up Dosing in Healthy Adult Participants". The purpose of the study is to assess the tolerability, safety, and pharmacokinetics of HYQVIA with ramp-up and no ramp-up dosing in healthy adult participants.

What is the current status of trial NCT04578535?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 51 participants. The study started on 2020-10-27. Estimated completion is 2022-03-02.

What interventions are being tested in trial NCT04578535?

The interventions under investigation include: HYQVIA (DRUG).

Who is sponsoring clinical trial NCT04578535?

This trial is sponsored by Baxalta now part of Shire, which has 74 total clinical trials registered on ClinicalTrials.gov.

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.