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 @ 9:49 PM
Ignite Modification Date:
2025-12-24 @ 9:49 PM
NCT ID:
NCT04983732
Brief Summary:
This will be a single-center, randomized, open-label, single dose, parallel study to assess the absolute bioavailability of FL-101 when administered via the subcutaneous (SC) and intravenous (IV) routes.
Detailed Description:
This single-center, randomized, open-label, single dose, parallel study will assess the absolute bioavailability of 150 mg FL-101 when administered via the SC and IV routes. The study will consist of a Screening Period (up to 28 days), followed by Baseline assessments and an inpatient Study Treatment Period of 24 hours (Day 1 and Day 2). Subjects will return to the clinic as outpatients for study procedures including, but not limited to, blood samples to be obtained for both PK and antibody assessments at pre-specified time points.
Study:
NCT04983732
Study Brief:
Protocol Section:
NCT04983732