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SIF001 Study for Epilepsy and Healthy Volunteers

This study is testing a new treatment called SIF001, which is a monoclonal antibody (a type of protein that can target specific cells or substances in the body). It's being given as an intravenous infusion (into a vein) every two weeks. The study aims to see how safe SIF001 is, how well people tolerate it, and how it moves through and affects the body. We are looking for both healthy volunteers and people with epilepsy, aged 18 to 70. The main goal is to track any side effects and their rates, comparing SIF001 to a placebo (an inactive substance). The study plans to enroll 88 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It is a dose escalation study, which means different groups will receive increasing doses of SIF001.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
For some participants, side effects will be tracked from Day 1 to Day 15. For others, this tracking will continue from Day 1 to Day 43.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07051629

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

Recruiting
PHASE1Ages 18–70InterventionalTreatment
Suninflam Inc
~88 participants
Updated 2026-06-15 on ClinicalTrials.gov
What's tested:SIF001Placebo

At a glance

Recruiting sites
10 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Numbers of participants and rate of treatment-related adverse events assessed by dose group and by active treatment vs placebo
Measured over Day 1 to Day 15 for SAD, and Day 1 to Day 43 for MAD

Conditions

Epilepsy
Healthy Volunteer

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Healthy VolunteerSeizure Disorder

Where it's being run

10 sites across 8 states
Florida3
Arizona1
Hawaii1
Maryland1
Michigan1
New York1
North Carolina1
Texas1

Who to contact

Dongxu Sun, PhD
[email protected]
6507850225
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

Healthy Volunteers (Stage I and II (Phase 1a and 1b)):

What this trial measures

  • Numbers of participants and rate of treatment-related adverse events assessed by dose group and by active treatment vs placeboDay 1 to Day 15 for SAD, and Day 1 to Day 43 for MAD

    To measure the incidence and severity of adverse events (AEs) and severe adverse events (SAEs), clinical laboratory parameters, vital signs, and physical examinations,