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
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)
Male or female 18 to 70 years of age at the time of signing the informed consent.
Subjects 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 half-lives of the respective drug, if known (whichever is longer), prior to dosing.
Acute precipitant of seizure within the past 3 months prior to screening such as major trauma, hypoglycemia, hyperglycemia, cardiac arrest, or post-anoxia
Any uncontrolled medical or psychiatric condition (e.g., hypertension, diabetes, chronic obstructive pulmonary disorder, asthma, depression) as judged by the investigator.
Sequential
SIF001
Biological/VaccineSIF001 intravenous infusion every two weeks
Placebo
DrugPlacebo
Numbers of participants and rate of treatment-related adverse events assessed by dose group and by active treatment vs placebo
To measure the incidence and severity of adverse events (AEs) and severe adverse events (SAEs), clinical laboratory parameters, vital signs, and physical examinations,
Pharmacokinetic (PK) parameters/ profiles:Area under the plasma concentration versus time curve (AUC)
PK: AUC D0-∞
Pharmacokinetic (PK) profile/parameters: Maximum observed plasma concentration
PK: Cmax
Pharmacokinetic (PK) profile/parameters: Time at which maximum plasma concentration occurs
PK: tmax
Pharmacokinetic (PK) profile/parameters: terminal elimination phase half life
PK: t(1/2)
Click on the lead sponsor to view all of their trials.
