EpilepsyPhase 1NCT07051629
Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics And Pharmacodynamics of SIF001 in Healthy Subjects and in Epilepsy Patients
A Phase 1 study testing SIF001 in people with Epilepsy and Healthy Volunteer, run by Suninflam Inc at 10 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Epilepsy, Healthy Volunteer
- What is being tested?
- SIF001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 10 sitesUnited States
- Study dates
- 16 Jun 2025to 15 Mar 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -
- Healthy Volunteers Only (Stage I and II (Phase 1a and 1b)):
- 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)
- Patients with Epilepsy Only (Stage II (Phase 1b)):
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- Male or female 18 to 70 years of age at the time of signing the informed consent.
- A clinical diagnosis of focal or generalized epilepsy. Subjects must have motor seizures, with or without impaired awareness.
- Has a minimum of 4 seizures per 4-week period while taking 1 to 3 anti-seizure medications
- All medications and epilepsy interventions must be stable for 8 weeks before screening and are expected to remain stable during the study
- All Subjects:
- 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.
- Female participants of child-bearing potential and male participants must agree to use adequate contraception for the duration of the protocol.
- Able to sign informed consent and comply with the protocol.
Who cannot join
- Healthy Volunteers (Stage I and II (Phase 1a and 1b)):
- 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.
- Patients with Epilepsy (Stage II (Phase 1b)):
- 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:
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- Any uncontrolled medical or psychiatric condition (e.g., hypertension, diabetes, chronic obstructive pulmonary disorder, asthma, depression) as judged by the investigator.
- Any clinically significant findings in medical examination, including physical examination, 12-lead ECG, vital signs, clinical laboratory tests. Specifically:
- alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 × upper limit of normal (ULN), Total bilirubin ≥ 2 × ULN
- QT interval corrected by Fridericia's formula (QTcF) > 450 msec (male) or > 470 msec (female)
- Undergone major surgery ≤ 2 months prior to Day -1.
- Received any investigational drug within 30 days or 5 half-lives (whichever is longer, if known) before screening.
- Received any vaccine within 6 weeks before planned SIF001 administration.
- 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.
- Active liver disease or severe renal impairment, including serum creatinine ≥ 1.5 × ULN or estimated glomerular filtration rate of < 60 mL/min/1.73m2.
- Known history of substance use disorder.
- History of active human immunodeficiency virus (HIV), active hepatitis C virus (HCV), or active hepatitis B virus (HBV)
- 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.
- Known history of hypersensitivity or anaphylactic reaction to intravenous medications, biologicals, or fluids.
- 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.
- History of status epilepticus within 2 years of screening
- 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)
- Unable to complete this study for other reasons or the investigator believes that the subject should be excluded.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites, 10 recruiting
- Recruiting
Dent Neurologic Institute
Amherst, New York, 14226
Jacara Washington, 716-961-9220, jwashington@dentinstitute.com
- Recruiting
Mid-Atlantic Epilepsy and Sleep Center
Bathesda, Maryland, 20817
Pavel Klein, MD, 301-530-9744, kleinp@epilepsydc.com
- Recruiting
OnSite Clinical Solutions, LLC
Charlotte, North Carolina, 28277
Kenneth Ashkin, MD, 800-785-3150, kashkinMD@onsiteclinical.com
- Recruiting
Horizon Clinical Research Center
Cypress, Texas, 77429
Harpaul Gill, MD, 281-803-9960, trials@horizoncrg.com
- Recruiting
Accel Research sites network
DeLand, Florida, 32720
Michael Hoffmann, MD, 3867852400, machael.hoffmann@accelclinical.com
- Recruiting
Quest Research Institute
Farmington Hills, Michigan, 48334
Aaron Ellenbogen, DO, 2489578940, aaron@questri.com
- Recruiting
Hawaii Pacific Neuroscience, Comprehensive Epilepsy Center
Honolulu, Hawaii, 96817
Darren Dugas, MD, 800-564-6141, info@hawaiineuroscience.com
- Recruiting
D&H Tamarac Research Center, LLC
Tamarac, Florida, 33321
Neri Barnea, MD, 786-375-6210, drbarnea@nrcinc.com
- Recruiting
Center for Neurosciences
Tucson, Arizona, 85718
Crystal Placencia, BS, 520-529-5234, ClinicalTrials@neurotucson.com
- Recruiting
Encore Medical Research of Weston, LLC
Weston, Florida, 33331
Ninett Llerena, RN, 954-777-8827, nllerena@encoremedicalresearch.com
About this study
Official title: 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
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
Read the detailed 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.
- Conditions
- Epilepsy, Healthy Volunteer
- Being tested
- SIF001, Placebo
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIF001Biological
SIF001 intravenous infusion every two weeks
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| SIF001 10-80mg/kg IV | Experimental | SIF001 infused intravenously over one hour Receives: Biological: SIF001 |
| Placebo | Placebo comparator | Placebo infused intravenously over one hour Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numbers of participants and rate of treatment-related adverse events assessed by dose group and by active treatment vs placebo
To measure the incidence and severity of adverse events (AEs) and severe adverse events (SAEs), clinical laboratory parameters, vital signs, and physical examinations,
Measured: Day 1 to Day 15 for SAD, and Day 1 to Day 43 for MAD
Secondary outcomes (8)
Pharmacokinetic (PK) parameters/ profiles:Area under the plasma concentration versus time curve (AUC)
PK: AUC D0-∞
Measured: Through Day 75
Pharmacokinetic (PK) profile/parameters: Maximum observed plasma concentration
PK: Cmax
Measured: Through Day 75
Pharmacokinetic (PK) profile/parameters: Time at which maximum plasma concentration occurs
PK: tmax
Measured: Through Day 75
Pharmacokinetic (PK) profile/parameters: terminal elimination phase half life
PK: t(1/2)
Measured: Through Day 75
Pharmacokinetic (PK) profile/parameters: total clearance
PK: CL
Measured: Through Day 75
Pharmacokinetic (PK) profile/parameters: volume of distribution
PK: Vd
Measured: Through Day 75
Incidence of immunogenicity of SIF001 (production of anti-SIF001 antibodies)
Detection of anti-SIF001 antibodies
Measured: Through Day 75
To evaluate the change from baseline in seizure frequency (patient cohort only)
Frequency of observed countable seizures with motor manifestations, with or without impaired awareness
Measured: from Day 1 to 29 (4 weeks), from Day 29 to 57 (4 weeks), and up to Day 57 in patients with epilepsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2025
- Study start16 Jun 2025
- Primary completion15 Jan 2027 (estimated)
- Study completion15 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- The study has two stages. Healthy volunteers in stage 1 of a single ascending dose (SAD) study and in stage 2 of a multiple ascending dose (MAD) study will receive a starting dose of 10mglkg, followed by ascending doses of 20, 50 and 80mg/kg. A cohort of epilepsy patients will be added to stage 2.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suninflam Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07051629
- Sponsor's protocol ID
- SIF001-001
- Status last verified
- Jun 2026
- First submitted
- 17 Jun 2025
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07051629
- Acronym / sponsor ID
- SIF001-001
- Conditions
- Epilepsy, Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Suninflam IncIndustry (pharma, biotech, devices)
- Study start
- 16 Jun 2025 (actual)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 15 Mar 2027 (estimated)
- First posted
- 4 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study has two stages. Healthy volunteers in stage 1 of a single ascending dose (SAD) study and in stage 2 of a multiple ascending dose (MAD) study will receive a starting dose of 10mglkg, followed by ascending doses of 20, 50 and 80mg/kg. A cohort of epilepsy patients will be added to stage 2.
| Arm | Type | Receives |
|---|---|---|
| SIF001 10-80mg/kg IV | Experimental | Biological: SIF001SIF001 infused intravenously over one hour |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo infused intravenously over one hour |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- -
- 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.
Key exclusion criteria (23 listed)
- Healthy Volunteers (Stage I and II (Phase 1a and 1b)):
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SIF001SIF001 intravenous infusion every two weeks | Biological | SIF001 10-80mg/kg IV |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Numbers of participants and rate of treatment-related adverse events assessed by dose group and by active treatment vs placebo
Time frame: Day 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,
8 secondary outcomes
Pharmacokinetic (PK) parameters/ profiles:Area under the plasma concentration versus time curve (AUC)
Time frame: Through Day 75
Pharmacokinetic (PK) profile/parameters: Maximum observed plasma concentration
Time frame: Through Day 75
Pharmacokinetic (PK) profile/parameters: Time at which maximum plasma concentration occurs
Time frame: Through Day 75
Pharmacokinetic (PK) profile/parameters: terminal elimination phase half life
Time frame: Through Day 75
Pharmacokinetic (PK) profile/parameters: total clearance
Time frame: Through Day 75
Pharmacokinetic (PK) profile/parameters: volume of distribution
Time frame: Through Day 75
Incidence of immunogenicity of SIF001 (production of anti-SIF001 antibodies)
Time frame: Through Day 75
To evaluate the change from baseline in seizure frequency (patient cohort only)
Time frame: from Day 1 to 29 (4 weeks), from Day 29 to 57 (4 weeks), and up to Day 57 in patients with epilepsy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SIF001 in people with Epilepsy and Healthy Volunteer, run by Suninflam Inc at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dongxu Sun, PhD (6507850225, dsun@suninflam.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numbers of participants and rate of treatment-related adverse events assessed by dose group and by active treatment vs placebo (time frame: Day 1 to Day 15 for SAD, and Day 1 to Day 43 for MAD). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.