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

NCT04983732 | Completed Phase 1 FDA Drug

• 1 other identifier: FL-101-1001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subjects

Keywords

Absolute Bioavailability

Outcome Measures

Primary Outcomes (1)

• FL-101 Absolute Bioavailability

  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.

  Day 1 to Day 85

Secondary Outcomes (2)

• Serum concentration of FL-101

  Day 1 to Day 85

• Incidence of adverse events

  Day 1 to Day 85

Other Outcomes (1)

• FL-101 Antibodies

  Day 1 (predose) and Days 8, 15, 22, 29, 43, 57, 71, and 85

Study Arms (2)

FL-101-IV

EXPERIMENTAL

FL-101 single IV infusion over 60-minutes

Drug: FL-101-Intravenous

FL-101-SC

EXPERIMENTAL

FL-101 single SC injection

Drug: FL-101-Subcutaneous

Interventions

FL-101-Intravenous DRUG

150 mg administered via the IV route

FL-101-IV

FL-101-Subcutaneous DRUG

150 mg administered via the SC route

FL-101-SC

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)
• Note: If vital signs are out of range, the Investigator may obtain one additional reading, so that up to two consecutive assessments are made within 1 hour, and with the volunteer semi-reclined quietly during the 5 minutes preceding the assessment.
• A 12-lead ECG consistent with normal cardiac conduction and function at Screening, including: HR between 45 and 100 bpm; QTcF interval ≤460 ms; QRS interval \<120 ms; PR interval \<220 ms; and morphology consistent with healthy cardiac conduction and function.
• Nonsmoker within the previous 6 months (before Screening), and does not use tobacco containing, or nicotine-containing products (including, but not limited to, cigarettes, pipes, cigars, chewing tobacco, e-cigarettes, nicotine patch, or nicotine gum).
• Has clinical chemistry, hematology, coagulation, and complete urinalysis (fasted for at least 6 hours) results at Screening and at admission within the reference range for the testing laboratory unless the out-of-range results are deemed not clinically significant by the Investigator and the Sponsor.
• Has adequate renal function at Screening and at admission as evidenced by creatinine clearance ≥ 90 mL/min by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) estimation.

You may not qualify if:

• 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.
• Has a positive test for drugs of abuse at Screening or alcohol 3 days prior to dosing or is unwilling to abstain from alcohol and drugs of abuse throughout the study.
• Has a smoking history during the past 6 months before Screening. This includes the use of any nicotine-containing substances (e.g., nicotine patch or gum, chewing tobacco, e-cigarettes), or has a positive cotinine test at Screening, or is unwilling to abstain from these products for the duration of the study.
• Has used any investigational compound or an experimental medical device, within 30 days prior to receiving the study drug.
• If male, the subject intends to impregnate others, or donate sperm within 90 days (3 months) after receiving the study drug.
• Has inadequate venous access for the required blood draws for the study.

Sponsors & Collaborators

• Flame Biosciences: lead

Study Sites (1)

Axis Clinicals

Dilworth, Minnesota, 56529, United States

Location

Study Officials

• Swarna Yadlapalli, MD

  Axis Clinicals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2021
• First Posted: July 30, 2021
• Study Start: September 11, 2021
• Primary Completion: May 5, 2022
• Study Completion: May 5, 2022
• Last Updated: June 1, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)