MedTrace Logo

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

NCT04983732 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-06-01

No results posted yet for this study

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.

Conditions

  • Healthy Subjects

Interventions

DRUG

FL-101-Intravenous

150 mg administered via the IV route

DRUG

FL-101-Subcutaneous

150 mg administered via the SC route

Sponsors & Collaborators

  • Flame Biosciences

    lead INDUSTRY

Principal Investigators

  • Swarna Yadlapalli, MD · Axis Clinicals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-11
Primary Completion
2022-05-05
Completion
2022-05-05
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04983732 on ClinicalTrials.gov