Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2025-12-28 @ 3:21 PM
Study NCT ID:
NCT04983732
Status:
COMPLETED
Last Update Posted:
2022-06-01
First Post:
2021-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Bioavailability Study of FL-101 in Healthy Male and Female Subjects
Sponsor:
Flame Biosciences
Organization:
Study Overview
Official Title:
A Randomized, Open-Label, Parallel Study to Evaluate the Absolute Bioavailability of FL-101 in Healthy Male and Female Subjects
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: