AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics And Pharmacodynamics of SIF001 in Healthy Subjects and in Epilepsy Patients

RecruitingPhase 1Ages 18 Years - 70 YearsAllSuninflam Inc
💬

In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: \- Healthy Volunteers Only (Stage I and II (Phase 1a and 1b)): 1. Male or female 18 to 55 years of age at the time of signing the informed consent. 2. In good health as determined by the Investigator, based on medical history and screening evaluations. 3. Body weight of ≥ 50 kg and BMI within the range 18-30 kg/m2 (inclusive) Patients with Epilepsy Only (Stage II (Phase 1b)): 4. Male or female 18 to 70 years of age at the time of signing the informed consent. 5. A clinical diagnosis of focal or generalized epilepsy. Subjects must have motor seizures, with or without impaired awareness. 6. Has a minimum of 4 seizures per 4-week period while taking 1 to 3 anti-seizure medications 7. All medications and epilepsy interventions must be stable for 8 weeks before screening and are expected to remain stable during the study All Subjects: 8. 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. 9. Female participants of child-bearing potential and male participants must agree to use adequate contraception for the duration of the protocol. 10. Able to sign informed consent and comply with the protocol. Exclusion Criteria: * Healthy Volunteers (Stage I and II (Phase 1a and 1b)): 1. Subjects with any unresolved history of clinically significant disease, in the opinion of the investigator. 2. 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 half-lives of the respective drug, if known (whichever is longer), prior to dosing. Patients with Epilepsy (Stage II (Phase 1b)): 3. Acute precipitant of seizure within the past 3 months prior to screening such as major trauma, hypoglycemia, hyperglycemia, cardiac arrest, or post-anoxia All Subjects: 4. Any uncontrolled medical or psychiatric condition (e.g., hypertension, diabetes, chronic obstructive pulmonary disorder, asthma, depression) as judged by the investigator. 5. Any clinically significant findings in medical examination, including physical examination, 12-lead ECG, vital signs, clinical laboratory tests. Specifically: 1. alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 × upper limit of normal (ULN), Total bilirubin ≥ 2 × ULN 2. QT interval corrected by Fridericia's formula (QTcF) \> 450 msec (male) or \> 470 msec (female) 6. Undergone major surgery ≤ 2 months prior to Day -1. 7. Received any investigational drug within 30 days or 5 half-lives (whichever is longer, if known) before screening. 8. Received any vaccine within 6 weeks before planned SIF001 administration. 9. 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. 10. Active liver disease or severe renal impairment, including serum creatinine ≥ 1.5 × ULN or estimated glomerular filtration rate of \< 60 mL/min/1.73m2. 11. Known history of substance use disorder. 12. History of active human immunodeficiency virus (HIV), active hepatitis C virus (HCV), or active hepatitis B virus (HBV) 13. 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. 14. Known history of hypersensitivity or anaphylactic reaction to intravenous medications, biologicals, or fluids. 15. 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 ability to participate in the study. 16. History of status epilepticus within 2 years of screening 17. 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) 18. Unable to complete this study for other reasons or the investigator believes that the subject should be excluded.
💊

What it tests

  • SIF001
  • Placebo
📍

Where

10 sites
Center for Neurosciences
Tucson, United States
Accel Research sites network
DeLand, United States
D&H Tamarac Research Center, LLC
Tamarac, United States
Encore Medical Research of Weston, LLC
Weston, United States
Hawaii Pacific Neuroscience, Comprehensive Epilepsy Center
Honolulu, United States
Mid-Atlantic Epilepsy and Sleep Center
Bathesda, United States
Quest Research Institute
Farmington Hills, United States
Dent Neurologic Institute
Amherst, United States

…and 2 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy