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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSuninflam Inc

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • SIF001
  • Placebo

Treatment groups

88 Participants
are divided into 2 treatment groups

Sponsors and collaborators