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

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

Study Overview

• Status: Recruiting
• Conditions: Epilepsy; Healthy Volunteer
• Intervention / Treatment: Drug: Placebo; Biological: SIF001

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 Type: Interventional
• Enrollment (Estimated): 72
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Dongxu Sun, PhD; Phone Number: 6507850225; Email: dsun@suninflam.com

Study Locations

• United States
  • Florida
    • DeLand, Florida, United States, 32720
      • Recruiting
      • Accel Research Sites Network
      • Contact: Michael Hoffmann, MD; Phone Number: 3867852400; Email: machael.hoffmann@accelclinical.com
  • Michigan
    • Farmington Hills, Michigan, United States, 48334
      • Recruiting
      • Quest Research Institute
      • Contact: Aaron Ellenbogen, DO; Phone Number: 2489578940; Email: aaron@questri.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SIF001 10-20mg/kg IV; SIF001 infused intravenously over one hour	Biological: SIF001; SIF001 intravenous infusion every two weeks
Placebo Comparator: Placebo; Placebo infused intravenously over one hour	Drug: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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,	Day 1 to Day 15 for SAD, and Day 1 to Day 43 for MAD

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic (PK) profile/parameters: Maximum observed plasma concentration	PK: Cmax	Through Day 75
Pharmacokinetic (PK) profile/parameters: Time at which maximum plasma concentration occurs	PK: tmax	Through Day 75
Pharmacokinetic (PK) profile/parameters: terminal elimination phase half life	PK: t(1/2)	Through Day 75
Pharmacokinetic (PK) profile/parameters: total clearance	PK: CL	Through Day 75
Pharmacokinetic (PK) profile/parameters: volume of distribution	PK: Vd	Through Day 75
Pharmacokinetic (PK) parameters/ profiles:Area under the plasma concentration versus time curve (AUC)	PK: AUC D0-∞	Through Day 75
Incidence of immunogenicity of SIF001 (production of anti-SIF001 antibodies)	Detection of anti-SIF001 antibodies	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	from Day 1 to 29 (4 weeks), from Day 29 to 57 (4 weeks), and up to Day 57 in patients with epilepsy

Collaborators and Investigators

• Sponsor: Suninflam Inc

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2025
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): March 15, 2027

Study Registration Dates

• First Submitted: June 17, 2025
• First Submitted That Met QC Criteria: June 25, 2025
• First Posted (Actual): July 4, 2025

Study Record Updates

• Last Update Posted (Actual): July 4, 2025
• Last Update Submitted That Met QC Criteria: June 25, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: SIF001-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No