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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

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

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

Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics And Pharmacodynamics of SIF001 in Healthy Subjects and in Epilepsy Patients (NCT07051629) is a Phase 1 interventional studying Epilepsy and Healthy Volunteer, sponsored by Suninflam Inc. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Epilepsy, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 72 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Epilepsy subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: \- 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 willing to sign a consent form. 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 willing to sign a consent form. 5. A clinical diagnosis of focal or generalized epilepsy. Subjects must have motor seizures, with or without impaired awareness. 6. Has a minimum of 4 seizures per 4-week period while taking 1 to 3 anti-seizure medications 7. All medications and epilepsy interventions must be stable for 8 weeks before screening and are expected to remain stable during the study All Subjects: 8. Negative serum pregnancy test at screening and urine pregnancy test on Day -1 before starting study treatment in all pre-menopausal women and women \< 12 months after the onset of menopause. 9. Female participants of child-bearing potential and male participants must agree to use adequate contraception for the duration of the protocol. 10. Able to sign willing to sign a consent form and comply with the protocol. Who Should NOT Join This Trial: - Healthy Volunteers (Stage I and II (Phase 1a and 1b)): 1. Subjects with any unresolved history of clinically significant disease, in the opinion of the investigator. 2. 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. Patients with Epilepsy (Stage II (Phase 1b)): ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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 impaired awareness. 6. Has a minimum of 4 seizures per 4-week period while taking 1 to 3 anti-seizure medications 7. All medications and epilepsy interventions must be stable for 8 weeks before screening and are expected to remain stable during the study All Subjects: 8. Negative serum pregnancy test at screening and urine pregnancy test on Day -1 before starting study treatment in all pre-menopausal women and women \< 12 months after the onset of menopause. 9. Female participants of child-bearing potential and male participants must agree to use adequate contraception for the duration of the protocol. 10. Able to sign informed consent and comply with the protocol. Exclusion Criteria: * Healthy Volunteers (Stage I and II (Phase 1a and 1b)): 1. Subjects with any unresolved history of clinically significant disease, in the opinion of the investigator. 2. 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. Patients with Epilepsy (Stage II (Phase 1b)): 3. Acute precipitant of seizure within the past 3 months prior to screening such as major trauma, hypoglycemia, hyperglycemia, cardiac arrest, or post-anoxia All Subjects: 4. Any uncontrolled medical or psychiatric condition (e.g., hypertension, diabetes, chronic obstructive pulmonary disorder, asthma, depression) as judged by the investigator. 5. Any clinically significant findings in medical examination, including physical examination, 12-lead ECG, vital signs, clinical laboratory tests. Specifically: 1. alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 × upper limit of normal (ULN), Total bilirubin ≥ 2 × ULN 2. QT interval corrected by Fridericia's formula (QTcF) \> 450 msec (male) or \> 470 msec (female) 6. Undergone major surgery ≤ 2 months prior to Day -1. 7. Received any investigational drug within 30 days or 5 half-lives (whichever is longer, if known) before screening. 8. Received any vaccine within 6 weeks before planned SIF001 administration. 9. Loss of more than 100 mL blood (e.g., a blood donation) within 2 months before Day -1, or has received any blood, plasma, or platelet transfusions within 3 months before admission. 10. Active liver disease or severe renal impairment, including serum creatinine ≥ 1.5 × ULN or estimated glomerular filtration rate of \< 60 mL/min/1.73m2. 11. Known history of substance use disorder. 12. History of active human immunodeficiency virus (HIV), active hepatitis C virus (HCV), or active hepatitis B virus (HBV) 13. Recent (2 weeks) history of a positive COVID-19 test result or disease symptoms of COVID-19 disease such as shortness of breath, cough, rhinorrhea, sore throat etc. 14. Known history of hypersensitivity or anaphylactic reaction to intravenous medications, biologicals, or fluids. 15. History of any clinically significant disease or disorder which, in the opinion of the investigators, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study. 16. History of status epilepticus within 2 years of screening 17. Known history of suicidality within 2 years of screening, or answering "yes" to questions 4 and 5 of the Columbia Suicide Severity Rating Scale (C-SSRS) 18. Unable to complete this study for other reasons or the investigator believes that the subject should be excluded.

Treatments Being Tested

BIOLOGICAL

SIF001

SIF001 intravenous infusion every two weeks

DRUG

Placebo

Placebo

Locations (2)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Accel Research sites network
DeLand, Florida, United States
Quest Research Institute
Farmington Hills, Michigan, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07051629), the sponsor (Suninflam Inc), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07051629 clinical trial studying?

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 The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07051629?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07051629?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07051629. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07051629. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.