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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: Completed Phase 1 study, sponsored by Baxalta now part of Shire.
NCT04578535 is a Phase 1 study that has completed, run by Baxalta now part of Shire. The registered enrollment target is 51 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
A tolerability event was considered to have occurred if an infusion was tolerable. An infusion was considered tolerable if the infusion rate was not reduced, or the infusion was not interrupted or stopped, due to an adverse event (AE) related to HYQVIA infusion. Tolerability was measured in terms of the number of participants for which the infusions was tolerable. Number of participants who tolerated all initiated HYQVIA Infusion were reported.
Interventions
- DRUG HYQVIA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2020-10-27 |
| Est. Completion | 2022-03-02 |
| Phase | Phase 1 |
What the finished NCT04578535 record still lists
NCT04578535 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% lower).
The record links to 0 conditions, and to 1 intervention - of which HYQVIA is the first listed.
NCT04578535 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04578535's enrollment target sits among peer trials
51 969th of 2000 higher than 1,028 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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