Epilepsy study: SIF001
Official title Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics And Pharmacodynamics of SIF001 in Healthy Subjects and in Epilepsy Patients
ClinicalTrials.gov ID: NCT07051629
What this study is testing
What is SIF001?
SIF001 is an investigational medicine being studied as a potential treatment for epilepsy.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing how safe SIF001 is. It also looks at how the body handles the drug.
- Who it's for
- You may be able to join if you are healthy or have epilepsy.
- What's involved
- You would get a shot of SIF001. The team would check your blood to see how it works.
- Time commitment
- The study involves visits to check on your health over time.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70. Healthy volunteers may be eligible.
You may be able to join if
- Male or female 18 to 55 years of age at the time of signing the informed consent.
- In good health as determined by the Investigator, based on medical history and screening evaluations.
- Male or female 18 to 70 years of age at the time of signing the informed consent.
- A clinical diagnosis of focal or generalized epilepsy. people must have motor seizures, with or without impaired awareness.
- Has a minimum of 4 seizures per 4-week period while taking 1 to 3 anti-seizure medications
You likely can't join if
- people with any unresolved history of clinically significant disease, in the opinion of the investigator.
- Any uncontrolled medical or psychiatric condition (e.g., hypertension, diabetes, chronic obstructive pulmonary disorder, asthma, depression) as...
- alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 × upper limit of normal (ULN), Total bilirubin ≥ 2 × ULN
- QT interval corrected by Fridericia's formula (QTcF) \> 450 msec (male) or \> 470 msec (female)
- Undergone major surgery ≤ 2 months prior to Day -1.
- Received any investigational drug within 30 days or 5 half-lives (whichever is longer, if known) before screening.
See the full eligibility criteria
- Male or female 18 to 55 years of age at the time of signing the informed consent.
- In good health as determined by the Investigator, based on medical history and screening evaluations.
- Male or female 18 to 70 years of age at the time of signing the informed consent.
- A clinical diagnosis of focal or generalized epilepsy. people must have motor seizures, with or without impaired awareness.
- Has a minimum of 4 seizures per 4-week period while taking 1 to 3 anti-seizure medications
- Negative serum pregnancy test at screening and urine pregnancy test on Day -1 before starting study treatment in all pre-menopausal women and women \< 12 months after the onset of menopause.
- Female participants of child-bearing potential and male participants must agree to use adequate contraception for the duration of the protocol.
- Able to sign informed consent and comply with the protocol.
- people with any unresolved history of clinically significant disease, in the opinion of the investigator.
- Any uncontrolled medical or psychiatric condition (e.g., hypertension, diabetes, chronic obstructive pulmonary disorder, asthma, depression) as judged by the investigator.
- alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 × upper limit of normal (ULN), Total bilirubin ≥ 2 × ULN
- QT interval corrected by Fridericia's formula (QTcF) \> 450 msec (male) or \> 470 msec (female)
- Undergone major surgery ≤ 2 months prior to Day -1.
- Received any investigational drug within 30 days or 5 half-lives (whichever is longer, if known) before screening.
- Received any vaccine within 6 weeks before planned SIF001 administration.
- Loss of more than 100 mL blood (e.g., a blood donation) within 2 months before Day -1, or has received any blood, plasma, or platelet transfusions within 3 months before admission.
- Active liver disease or severe renal impairment, including serum creatinine ≥ 1.5 × ULN or estimated glomerular filtration rate of \< 60 mL/min/1.73m2.
- Known history of substance use disorder.
- History of active human immunodeficiency virus (HIV), active hepatitis C virus (HCV), or active hepatitis B virus (HBV)
- Recent (2 weeks) history of a positive COVID-19 test result or disease symptoms of COVID-19 disease such as shortness of breath, cough, rhinorrhea, sore throat etc.
- Known history of hypersensitivity or anaphylactic reaction to intravenous medications, biologicals, or fluids.
- History of any clinically significant disease or disorder which, in the opinion of the investigators, may either put the subject at risk because of participation in the study, or influence the results or the subject's...
- History of status epilepticus within 2 years of screening
- Known history of suicidality within 2 years of screening, or answering "yes" to questions 4 and 5 of the Columbia Suicide Severity Rating Scale (C-SSRS)
- Unable to complete this study for other reasons or the investigator believes that the subject should be excluded.
The study team makes the final eligibility decision.
Where it is enrolling
- Tucson, Arizona, United States
- DeLand, Florida, United States
- Tamarac, Florida, United States
- Weston, Florida, United States
- Honolulu, Hawaii, United States
- Bathesda, Maryland, United States
- Farmington Hills, Michigan, United States
- Amherst, New York, United States
- Charlotte, North Carolina, United States
- Cypress, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Tucson, Arizona, United States; DeLand, Florida, United States; Tamarac, Florida, United States; Weston, Florida, United States; Honolulu, Hawaii, United States; Bathesda, Maryland, United States and 4 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.