Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2025-12-24 @ 10:06 PM
NCT ID:
NCT04578535
Brief 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.
Detailed Description:
This study will comprise of Part 1 and Part 2. Each study part will consist of three treatment arms (Part 1 \[approximately 24 participants\]: Treatment Arms 1-3 and Part 2 \[approximately 24 participants\]: Treatment Arms 4-6). Treatment arms will be initiated in parallel within each study part. Each participant will participate in only one treatment arm. After participants in Treatment Arms 1-3 (Study Part 1) will complete Week 9, the tolerability and, safety data through Week 9 will be reviewed by a safety review team. (Participants in arms 1-3 will continue in the study as the safety review is being completed.) Once the safety review for Arms 1-3 (Study part 1) will be completed and approved, Treatment Arms 4-6 (Study Part 2) will begin.
Study:
NCT04578535
Study Brief:
Protocol Section:
NCT04578535