BridgeMD
Tests treatment safety and results for Epilepsy
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, given as an infusion into a vein, 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 is a dose escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of SIF001, a monoclonal antibody with the potential to treat epilespy
- 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
- \- Healthy Volunteers Only (Stage I and II (Phase 1a and 1b)):
- 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.
- Body weight of ≥ 50 kg and BMI within the range 18-30 kg/m2 (inclusive) Patients with Epilepsy Only (Stage II (Phase 1b)):
- Male or female 18 to 70 years of age at the time of signing the informed consent.
You likely can't join if
- Healthy Volunteers (Stage I and II (Phase 1a and 1b)):
- people with any unresolved history of clinically significant disease, in the opinion of the investigator.
- Past or intended use of over-the-counter (OTC) or prescription medication (other than ≤ 2 g/day paracetamol [acetaminophen] or ≤ 800-mg/day...
- Acute precipitant of seizure within the past 3 months prior to screening such as major trauma, hypoglycemia, hyperglycemia, cardiac arrest, or...
- Any uncontrolled medical or psychiatric condition (e.g., hypertension, diabetes, chronic obstructive pulmonary disorder, asthma, depression) as...
- Any clinically significant findings in medical examination, including physical examination, 12-lead ECG, vital signs, clinical laboratory tests...
See the full eligibility criteria
- \- Healthy Volunteers Only (Stage I and II (Phase 1a and 1b)):
- 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.
- Body weight of ≥ 50 kg and BMI within the range 18-30 kg/m2 (inclusive) Patients with Epilepsy Only (Stage II (Phase 1b)):
- 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
- All medications and epilepsy interventions must be stable for 8 weeks before screening and are expected to remain stable during the study All people:
- 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.
- Healthy Volunteers (Stage I and II (Phase 1a and 1b)):
- people with any unresolved history of clinically significant disease, in the opinion of the investigator.
- Past or intended use of over-the-counter (OTC) or prescription medication (other than ≤ 2 g/day paracetamol [acetaminophen] or ≤ 800-mg/day ibuprofen), vitamins, and dietary or herbal supplements within 7 days or 5...
- Acute precipitant of seizure within the past 3 months prior to screening such as major trauma, hypoglycemia, hyperglycemia, cardiac arrest, or post-anoxia All people:
- Any uncontrolled medical or psychiatric condition (e.g., hypertension, diabetes, chronic obstructive pulmonary disorder, asthma, depression) as judged by the investigator.
- Any clinically significant findings in medical examination, including physical examination, 12-lead ECG, vital signs, clinical laboratory tests. Specifically:
- 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's taking place
- 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
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 - 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?
Study sites include 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 location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.