Healthy SubjectsPhase 1NCT04983732
A Bioavailability Study of FL-101 in Healthy Male and Female Subjects
A Phase 1 study testing FL-101-Intravenous and FL-101-Subcutaneous in people with Healthy Subjects, run by Flame Biosciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- FL-101-Intravenous and FL-101-Subcutaneous
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2021to 5 May 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
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- 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.
- Has adequate hepatic function at Screening and at admission as evidenced by the following: total bilirubin ≤ upper limit of normal (ULN); aspartate aminotransferase (AST) ≤ ULN and alanine aminotransferase (ALT) ≤ ULN.
- Has a negative urine drug screen result at Screening and at admission.
- Male subjects who are non-sterilized must agree to be sexually abstinent or use double barrier contraception (e.g., condom and spermicide) for 3 months (90 days) after receiving the study drug.
- Male subjects must agree to not donate sperm from Screening and at least 3 months (90 days) after receiving the study drug.
- Female subjects must be surgically sterilized, post-menopausal as defined by 1 year with no menses or using an adequate means of birth control if pre-menopausal.
Who cannot join
- 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
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- 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.
- Is unable to meet or perform study requirements, or has a known or suspected inability to comply with the study protocol.
- Is unable or unwilling to eat provided food (e.g., vegetarian, kosher, lactose intolerant dietary requirements).
- Is an immediate family member of the Investigator, or is an employee of the study center, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (e.g., spouse, parent, child, sibling) or may consent under duress.
- Has been on a significantly abnormal diet during the 4 weeks preceding the first dose of study drug based on Principal Investigator judgment.
- Use of any OTC medication (including nutritional or dietary supplements, herbal preparations, or vitamins) within 7 days prior to receiving the study drug until the end of study visit.
- Use of any prescription medication (except hormonal contraception) from 14 days prior to receiving the study drug until the end-of-study visit.
- Use of TNF-blocker within 30 days prior to receiving the study drug until 3 months (90 days) after receiving the study drug.
- Receipt of live or attenuated vaccine within 30 days prior to receiving the study drug until 3 months (90 days) after receiving the study drug. Subjects may receive the COVID-19 vaccine but must wait 2 weeks after receiving the 2nd dose of the vaccine to be enrolled into the study.
- Engagement in non-routine strenuous exercise from 48 hours prior to receiving the study drug until the end-of-study visit.
- Consumption of xanthines from 48 hours prior to admission until the end of study visit. Subjects will be instructed not to consume any of the above products; however, allowance for an isolated single incidental consumption may be evaluated and approved by the study Investigator based on the potential for interaction with the study drug.
- Has a positive test for HBsAg, HCV antibody, or HIV at Screening or has been previously treated for hepatitis B, hepatitis C, or HIV infection.
- Female subjects who are pregnant or lactating.
- Subjects who, in the opinion of the Investigator (or designee), should not participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-Label, Parallel Study to Evaluate the Absolute Bioavailability of FL-101 in Healthy Male and Female Subjects
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.
Read the 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
- Being tested
- FL-101-Intravenous, FL-101-Subcutaneous
- Keywords
- Absolute Bioavailability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FL-101-IntravenousDrug
150 mg administered via the IV route
FL-101-SubcutaneousDrug
150 mg administered via the SC route
| Study group | Role | What they receive |
|---|---|---|
| FL-101-IV | Experimental | FL-101 single IV infusion over 60-minutes Receives: Drug: FL-101-Intravenous |
| FL-101-SC | Experimental | FL-101 single SC injection Receives: Drug: FL-101-Subcutaneous |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 to Day 85
Secondary outcomes (2)
Serum concentration of FL-101
To characterize the PK of FL-101 administered via the SC and IV routes in healthy male and female subjects.
Measured: Day 1 to Day 85
Incidence of adverse events
To evaluate the safety and tolerability of FL-101 administered SC and IV in healthy male and female subjects.
Measured: Day 1 to Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start11 Sep 2021
- Primary completion5 May 2022
- Study completion5 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Flame Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Swarna Yadlapalli, MD, Principal investigator, Axis Clinicals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04983732
- Sponsor's protocol ID
- FL-101-1001
- Status last verified
- May 2022
- First submitted
- 22 Jul 2021
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Parallel Study to Evaluate the Absolute Bioavailability of FL-101 in Healthy Male and Female Subjects
- ClinicalTrials.gov ID
- NCT04983732
- Acronym / sponsor ID
- FL-101-1001
- Conditions
- Healthy Subjects
- Keywords
- Absolute Bioavailability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Flame BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 11 Sep 2021 (actual)
- Primary completion
- 5 May 2022 (actual)
- Study completion
- 5 May 2022 (actual)
- First posted
- 30 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FL-101-IV | Experimental | Drug: FL-101-IntravenousFL-101 single IV infusion over 60-minutes |
| FL-101-SC | Experimental | Drug: FL-101-SubcutaneousFL-101 single SC injection |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (20 listed)
- 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.
Key exclusion criteria (28 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FL-101-Intravenous150 mg administered via the IV route | Drug | FL-101-IV |
| FL-101-Subcutaneous150 mg administered via the SC route | Drug | FL-101-SC |
Primary outcome
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.
2 secondary outcomes
Serum concentration of FL-101
Time frame: Day 1 to Day 85
Incidence of adverse events
Time frame: Day 1 to Day 85
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Swarna Yadlapalli, MD principal investigator
Axis Clinicals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FL-101-Intravenous and FL-101-Subcutaneous in people with Healthy Subjects, run by Flame Biosciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FL-101 Absolute Bioavailability (time frame: Day 1 to Day 85). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2022.