A Phase 1, Double-Blind, Placebo-Controlled, Randomized, Single and Multiple Ascending Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SIF001 in Healthy Subjects and in a Patient Cohort With Epilepsy
Suninflam Inc
Summary
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
Description
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.
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- Yes
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…
Interventions
- BiologicalSIF001
SIF001 intravenous infusion every two weeks
- DrugPlacebo
Placebo
Locations (2)
- Accel Research sites networkDeLand, Florida
- Quest Research InstituteFarmington Hills, Michigan