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

Flame Biosciences1 site in 1 country24 target enrollmentSeptember 11, 2021

ConditionsHealthy Subjects

InterventionsFL-101-Intravenous FL-101-Subcutaneous

DrugsFL-101-Intravenous FL-101-Subcutaneous

Overview

Phase: Phase 1
Intervention: FL-101-Intravenous
Conditions: Healthy Subjects
Sponsor: Flame Biosciences
Enrollment: 24
Locations: 1
Primary Endpoint: FL-101 Absolute Bioavailability
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 11, 2021

End Date

May 5, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Flame Biosciences

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy male and female subjects between the ages of 18 and 55 years, inclusive, at Screening.
•Willing and able to provide written informed consent prior to participating in the study.
•Able to communicate clearly with the Investigator and staff; able to read, and understand study procedures.
•Able to complete all Screening period evaluations, stay in the clinical research facility for the duration of the inpatient portion of the study, and attend scheduled follow-up visits by videoconference or teleconference, and/or in-person as needed. In the case of neutropenia, subject must be willing and able to return for follow-up blood counts, including after EOS (Day 85) visit.
•BMI between 18 and 32.49 kg/m2, inclusive, and body weight not less than 50 kg.
•In good general health, free from clinically significant medical or psychiatric illness or disease (as determined by medical/surgical history, physical examination, weight, 12-lead ECG, and clinical laboratory tests).
•Vital signs at Screening must be within the following ranges and stable (measured in semi-reclined position after at least 5 minutes of rest):
•SBP ≥90 and ≤150 mmHg
•DBP ≥50 and ≤95 mmHg
•HR ≥45 and ≤100 beats per minute (bpm)

Exclusion Criteria

•Has a history of or current clinically significant medical illness including (but not limited to) pulmonary, cardiovascular, renal, coagulation disorders, lipid abnormalities, gastrointestinal, immunologic, endocrine, neurologic, psychiatric, or thromboembolic disease, metabolic disturbances, or any other current physical condition that the Investigator (or designee) considers should exclude the participant, or that could interfere with the interpretation of the study results.
•Has any clinically significant medical condition, physical examination finding, ECG abnormality, or clinically significant abnormal value for clinical chemistry, hematology, coagulation, or urinalysis at Screening or at admission to the study center, as deemed appropriate by the Investigator (or designee).
•History or presence of malignancy within the past 5 years, with the exception of adequately treated localized skin cancer (basal cell or squamous cell carcinoma), which is allowed.
•Currently suffers from clinically significant systemic allergic disease, or has a history of significant drug allergies, including but not limited to:
•A history of anaphylactic reaction
•Allergic reaction due to any drug that led to significant morbidity
•Known hypersensitivity to any component of the formulation of test article (FL-101).
•Has donated or intends to donate blood or blood products or has had an acute loss of blood (\>500 mL) during the 60 days before study drug administration (10 days for plasma donation) or intends to donate blood or blood products within 2 months after the completion of the study.
•Has had an acute, clinically significant illness within 30 days prior to Day 1, or has had a recent febrile illness with an abnormal body temperature within 72 hours prior to admission.
•Has a history within the past 24 months before Screening of drug abuse (defined as any illicit drug use), or a history of alcohol abuse (defined as alcohol consumption exceeding 14 units per week). One unit of alcohol equals 360 mL (12 oz.) of beer, 45 mL (1.5 oz.) of liquor, or 150 mL (5 oz.) of wine.

Arms & Interventions

FL-101-IV

FL-101 single IV infusion over 60-minutes

Intervention: FL-101-Intravenous

FL-101-SC

FL-101 single SC injection

Intervention: FL-101-Subcutaneous

Outcomes

Primary Outcomes

FL-101 Absolute Bioavailability

Time Frame: Day 1 to Day 85

To determine the absolute bioavailability of FL-101 administered as a single dose via subcutaneous (SC) administration relative to a single intravenous (IV) dose in healthy male and female subjects.