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
Nonclinical studies including disease animal model studies and toxicological studies indicate that SIF001 has the potential to be a therapeutical agent for epilepsy treatment through addressing the underlying pathology. This a phase 1 dose escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of SIF001 in healthy subjects and in a patient cohort with epilepsy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
88
Center for Neurosciences
Tucson, Arizona, United States
RECRUITINGAccel Research sites network
DeLand, Florida, United States
RECRUITINGNumbers 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,
Time frame: Day 1 to Day 15 for SAD, and Day 1 to Day 43 for MAD
Pharmacokinetic (PK) parameters/ profiles:Area under the plasma concentration versus time curve (AUC)
PK: AUC D0-∞
Time frame: Through Day 75
Pharmacokinetic (PK) profile/parameters: Maximum observed plasma concentration
PK: Cmax
Time frame: Through Day 75
Pharmacokinetic (PK) profile/parameters: Time at which maximum plasma concentration occurs
PK: tmax
Time frame: Through Day 75
Pharmacokinetic (PK) profile/parameters: terminal elimination phase half life
PK: t(1/2)
Time frame: Through Day 75
Pharmacokinetic (PK) profile/parameters: total clearance
PK: CL
Time frame: Through Day 75
Pharmacokinetic (PK) profile/parameters: volume of distribution
PK: Vd
Time frame: Through Day 75
Incidence of immunogenicity of SIF001 (production of anti-SIF001 antibodies)
Detection of anti-SIF001 antibodies
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D&H Tamarac Research Center, LLC
Tamarac, Florida, United States
RECRUITINGEncore Medical Research of Weston, LLC
Weston, Florida, United States
RECRUITINGHawaii Pacific Neuroscience, Comprehensive Epilepsy Center
Honolulu, Hawaii, United States
RECRUITINGMid-Atlantic Epilepsy and Sleep Center
Bathesda, Maryland, United States
RECRUITINGQuest Research Institute
Farmington Hills, Michigan, United States
RECRUITINGDent Neurologic Institute
Amherst, New York, United States
RECRUITINGOnSite Clinical Solutions, LLC
Charlotte, North Carolina, United States
RECRUITINGHorizon Clinical Research Center
Cypress, Texas, United States
RECRUITINGTime frame: Through Day 75
To evaluate the change from baseline in seizure frequency (patient cohort only)
Frequency of observed countable seizures with motor manifestations, with or without impaired awareness
Time frame: from Day 1 to 29 (4 weeks), from Day 29 to 57 (4 weeks), and up to Day 57 in patients with epilepsy