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 @ 2:14 PM
Ignite Modification Date:
2025-12-24 @ 2:14 PM
NCT ID:
NCT04184895
Brief Summary:
The purpose of this study is to evaluate the safety and tolerability of multiple ascending intradermal doses of ASP2390 in adult male and female participants allergic to house dust mites (HDM).
This study will also evaluate the effect of multiple ascending intradermal doses of ASP2390 on HDM-specific immunoglobulin G subclass 4 (IgG4) levels in adult male and female participants allergic to HDM.
Detailed Description:
Screening will occur up to 6 weeks prior to enrollment. Eligible participants will return to the clinical unit on day -1 (if required by the clinical unit to facilitate the severe acute respiratory syndrome coronavirus 2 \[SARS-CoV-2\] real-time reverse transcription polymerase chain reaction \[PCR\] procedure) or on day 1.
After the first dose on day 1, all participants will remain in the clinical unit for observation for approximately 24 hours postdose. After the 24 hours, participants will be discharged from the clinical unit provided no reactions have occurred that require additional observation.
For all subsequent doses, participants will remain under direct observation for a minimum of 1 hour postdose. Participants will be discharged from the clinical unit provided no reactions have occurred that require additional observation.
Study:
NCT04184895
Study Brief:
Protocol Section:
NCT04184895