NCT04983732

A Bioavailability Study of FL-101 in Healthy Male and Female Subjects

A Randomized, Open-Label, Parallel Study to Evaluate the Absolute Bioavailability of FL-101 in Healthy Male and Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Flame Biosciences · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	FL-101-Intravenous	150 mg administered via the IV route
DRUG	FL-101-Subcutaneous	150 mg administered via the SC route

Timeline

• Start date: 2021-09-11
• Primary completion: 2022-05-05
• Completion: 2022-05-05
• First posted: 2021-07-30
• Last updated: 2022-06-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study