Parkinson's DiseasePhase 1NCT04165837
Safety, Tolerability, and Pharmacokinetics of Oral FB-101 in Healthy Subjects
A Phase 1 study testing FB-101 in people with Parkinson's Disease, run by 1ST Biotherapeutics, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of oral doses of FB-101 in healthy subjects. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- FB-101
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2019to 14 Jul 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 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, adult, male or female (of non childbearing potential only) 19 55 years of age, inclusive, at screening.
- Continuous non smoker who has not used nicotine containing products for at least 3 months prior to (the first) dosing and throughout the study, based on subject self reporting.
- Body mass index (BMI) ≥ 18 and ≤ 32.0 kg/m2 at screening.
- Medically healthy with no clinically significant medical history, physical examination, neurological examination, ophthalmic examination, laboratory profiles, vital signs or ECGs, as deemed by the PI or designee.
- A female subject must be of non childbearing potential and must have undergone one of the following sterilization procedures at least 6 months prior to (the first) dosing:
- hysteroscopic sterilization;
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- bilateral tubal ligation or bilateral salpingectomy;
- hysterectomy;
- bilateral oophorectomy; or
- be postmenopausal with amenorrhea for at least 1 year prior to (the first) dosing and follicle stimulating hormone (FSH) serum levels consistent with postmenopausal status.
- A non vasectomized, male subject must agree to use a condom with spermicide or abstain from sexual intercourse during the study until 90 days after (the last) dosing. (No restrictions are required for a vasectomized male provided his vasectomy has been performed 4 months or more prior to (the first) dosing of study drug. A male who has been vasectomized less than 4 months prior to study (first) dosing must follow the same restrictions as a non vasectomized male).
- If male, must agree not to donate sperm from the first dosing until 90 days after (the last) dosing.
- Able to swallow multiple capsules.
- Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.
Who cannot join
- 1. Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
- 2. History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
- 3. History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
- 4. Is at suicidal risk in the opinion of the PI as per the following criteria:
- Any suicide attempts within 12 months prior to screening or any suicidal intent, including a plan, within 3 months prior to screening.
- C-SSRS answer of "YES" on suicidal ideation within 3 months prior to screening. 5. History or presence of alcoholism or drug abuse within the past 2 years prior to (the first) dosing.
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- 6. History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds.
- 7. History of allergy to lignocaine/fluorescein (LF) or tropicamide (T) (eye examination agents).
- 8. History of seizures (childhood febrile seizures are excepted). 9. Female subjects of childbearing potential. 10. Female subjects with a positive pregnancy test or who are lactating. 11. Positive urine drug or alcohol results at screening or check in. 12. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
- 13. Supine blood pressure is less than 90/40 mmHg or greater than 140/90 mmHg at screening.
- 14. Supine heart rate is lower than 40 bpm or higher than 99 bpm at screening. 15. Estimated creatinine clearance <90 mL/min at screening. 16. Unable to refrain from or anticipates the use of any drug including prescription and non prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to the first dosing and throughout the study. Drugs known to be significant inducers of cytochrome P450 (CYP) enzymes and/or P-glycoprotein (P gp), including St. John's Wort will be prohibited for 28 days prior to the first dosing and throughout the study. After dosing, acetaminophen (up to 2 g per 24 hours) may be administered at the discretion of the PI or designee. For subjects having CSF sampling, topical medication for minor dermatological conditions, stool softeners, local anesthetics, and/or intravenous normal saline may be permitted as appropriate for lumbar puncture procedure for CSF sample collection at the discretion of the PI.
- 17. Has been on a diet incompatible with the on study diet, in the opinion of the PI or designee, within the 30 days prior to (the first) dosing and throughout the study.
- 18. Donation of blood or significant blood loss within 56 days prior to (the first) dosing.
- 19. Plasma donation within 7 days prior to (the first) dosing. 20. Participation in another clinical study within 30 days prior to the (first) dosing. The 30 day window will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 (of Period 1 for the Fed Cohort) of the current study.
- 21. History or presence of: risk factors for Torsade de Pointes (e.g., heart failure, cardiomyopathy, or family history of Long QT Syndrome); sick sinus syndrome, second or third degree atrioventricular block, myocardial infarction, pulmonary congestion, symptomatic or significant cardiac arrhythmia, prolonged QTcF interval, or conduction abnormalities.
- 22. Has an abnormal screening ECG indicating a second- or third- degree AV block, or one or more of the following: QRS > 120 msec, QTcF > 450 msec for males and > 460 msec for females, PR interval > 220 msec. Any rhythm other than normal sinus rhythm, which is interpreted by the PI or designee to be clinically significant at screening or check-in.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral FB-101 in Healthy Subjects
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of oral doses of FB-101 in healthy subjects.
Read the detailed description
Part A
- To assess the safety and tolerability of single ascending oral doses of FB-101 in healthy subjects.
- To assess the pharmacokinetics (PK) of single ascending oral doses of FB-101 in healthy subjects.
- To assess the effect of a high-fat meal on the PK of a single oral dose of FB-101 when administered to healthy subjects.
Part B
- To assess the safety and tolerability of multiple ascending oral doses FB-101 in healthy subjects.
- To assess the PK of multiple ascending oral doses of FB-101 in healthy subjects.
- Conditions
- Parkinson's Disease
- Being tested
- FB-101, Placebo
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FB-101Drug
Part A - Single Ascending Dose study Part B - Multiple Ascending Dose study
PlaceboDrug
Part A - Single Ascending Dose matching placebo study Part B - Multiple Ascending Dose matching placebo study
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Not described Receives: Drug: FB-101 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and severity of treatment emergent adverse events (TEAEs)
To assess the safety and tolerability of single and multiple ascending oral doses of FB-101 in healthy adult subjects
Measured: 7 days after the last dose
Secondary outcomes (4)
Peak plasma concentration of FB-101 in plasma
PK of FB-101
Measured: 72 hours after the last dose
Area under the plasma concentration versus time curve of FB-101 in plasma
PK of FB-101
Measured: 72 hours after the last dose
Peak plasma concentration of FB-101 in plasma under fed condition
Food effect on the PK of FB-101
Measured: 72 hours after the last dose
Area under the plasma concentration versus time curve of FB-101 in plasma under fed condition
Food effect on the PK of FB-101
Measured: 72 hours after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start14 Oct 2019
- Primary completion12 Nov 2021
- Study completion14 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- 1ST Biotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04165837
- Sponsor's protocol ID
- 1ST-102-01
- Status last verified
- Jul 2022
- First submitted
- 13 Nov 2019
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral FB-101 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04165837
- Acronym / sponsor ID
- 1ST-102-01
- Conditions
- Parkinson's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- 1ST Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Oct 2019 (actual)
- Primary completion
- 12 Nov 2021 (actual)
- Study completion
- 14 Jul 2022 (actual)
- First posted
- 18 Nov 2019 (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.
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of oral doses of FB-101 in healthy subjects.
Detailed description
Part A
- To assess the safety and tolerability of single ascending oral doses of FB-101 in healthy subjects.
- To assess the pharmacokinetics (PK) of single ascending oral doses of FB-101 in healthy subjects.
- To assess the effect of a high-fat meal on the PK of a single oral dose of FB-101 when administered to healthy subjects.
Part B
- To assess the safety and tolerability of multiple ascending oral doses FB-101 in healthy subjects.
- To assess the PK of multiple ascending oral doses of FB-101 in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: FB-101 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Healthy, adult, male or female (of non childbearing potential only) 19 55 years of age, inclusive, at screening.
- Continuous non smoker who has not used nicotine containing products for at least 3 months prior to (the first) dosing and throughout the study, based on subject self reporting.
- Body mass index (BMI) ≥ 18 and ≤ 32.0 kg/m2 at screening.
- Medically healthy with no clinically significant medical history, physical examination, neurological examination, ophthalmic examination, laboratory profiles, vital signs or ECGs, as deemed by the PI or designee.
- A female subject must be of non childbearing potential and must have undergone one of the following sterilization procedures at least 6 months prior to (the first) dosing:
Key exclusion criteria (16 listed)
- 1. Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
- 2. History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
- 3. History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
- 6. History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds.
- 7. History of allergy to lignocaine/fluorescein (LF) or tropicamide (T) (eye examination agents).
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 |
|---|---|---|
| FB-101Part A - Single Ascending Dose study Part B - Multiple Ascending Dose study | Drug | Active |
| PlaceboPart A - Single Ascending Dose matching placebo study Part B - Multiple Ascending Dose matching placebo study | Drug | Placebo |
Primary outcome
Number and severity of treatment emergent adverse events (TEAEs)
Time frame: 7 days after the last dose
To assess the safety and tolerability of single and multiple ascending oral doses of FB-101 in healthy adult subjects
4 secondary outcomes
Peak plasma concentration of FB-101 in plasma
Time frame: 72 hours after the last dose
Area under the plasma concentration versus time curve of FB-101 in plasma
Time frame: 72 hours after the last dose
Peak plasma concentration of FB-101 in plasma under fed condition
Time frame: 72 hours after the last dose
Area under the plasma concentration versus time curve of FB-101 in plasma under fed condition
Time frame: 72 hours after the last dose
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 26 Jan 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 FB-101 in people with Parkinson's Disease, run by 1ST Biotherapeutics, Inc. 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 14 inclusion and 16 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 26 Jan 2023. 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. Some participants in this study may receive a placebo. 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?
Number and severity of treatment emergent adverse events (TEAEs) (time frame: 7 days after the last dose). 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 26 Jan 2023.