Actively Recruiting
Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics And Pharmacodynamics of SIF001 in Healthy Subjects and in Epilepsy Patients
Led by Suninflam Inc · Updated on 2025-07-04
72
Participants Needed
2
Research Sites
91 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics And Pharmacodynamics of SIF001 in Healthy Subjects and in Epilepsy Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy volunteers aged 18 to 55 years or patients with epilepsy aged 18 to 70 years
- Body weight of at least 50 kg and BMI between 18 and 30 kg/m2
- Patients with epilepsy must have a clinical diagnosis of focal or generalized epilepsy with motor seizures
- Patients must experience a minimum of 4 seizures per 4-week period while on 1 to 3 anti-seizure medications
- Epilepsy treatments and medications must be stable for at least 8 weeks before screening and expected to remain stable
- Negative pregnancy tests for all pre-menopausal women and women less than 12 months post-menopause
- Female participants of child-bearing potential and male participants agree to use adequate contraception
- Ability to provide informed consent and comply with study procedures
You will not qualify if you...
- History of any unresolved clinically significant disease (for healthy volunteers)
- Use of medications other than limited acetaminophen or ibuprofen within 7 days or 5 half-lives before dosing
- Acute seizure precipitant within 3 months prior to screening for epilepsy patients
- Uncontrolled medical or psychiatric conditions such as hypertension, diabetes, COPD, asthma, or depression
- Clinically significant abnormal laboratory or ECG findings, including liver enzyme elevations and prolonged QT interval
- Major surgery within 2 months before study start
- Participation in another investigational drug study within 30 days or 5 half-lives before screening
- Vaccination within 6 weeks before SIF001 administration
- Blood donation of more than 100 mL within 2 months or blood transfusion within 3 months before admission
- Active liver disease or severe kidney impairment
- History of substance use disorder
- Active HIV, hepatitis B, or hepatitis C infection
- Recent positive COVID-19 test or symptoms within 2 weeks
- History of hypersensitivity to intravenous medications or biologics
- History of status epilepticus within 2 years
- History of suicidality within 2 years or positive answers on Columbia Suicide Severity Rating Scale
- Any condition that may pose risk or interfere with study participation as judged by investigators
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Accel Research sites network
DeLand, Florida, United States, 32720
Actively Recruiting
2
Quest Research Institute
Farmington Hills, Michigan, United States, 48334
Actively Recruiting
Research Team
D
Dongxu Sun, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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