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

NCT07051629 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: SIF001-001
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Epilepsy; Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Pharmacokinetic (PK) parameters/ profiles:Area under the plasma concentration versus time curve (AUC)

  Through Day 75

• Pharmacokinetic (PK) profile/parameters: Maximum observed plasma concentration

  Through Day 75

• Pharmacokinetic (PK) profile/parameters: Time at which maximum plasma concentration occurs

  Through Day 75

• Pharmacokinetic (PK) profile/parameters: terminal elimination phase half life

  Through Day 75

• Pharmacokinetic (PK) profile/parameters: total clearance

  Through Day 75

Study Arms (2)

SIF001 10-20mg/kg IV

EXPERIMENTAL

SIF001 infused intravenously over one hour

Biological: SIF001

Placebo

PLACEBO COMPARATOR

Placebo infused intravenously over one hour

Drug: Placebo

Interventions

SIF001 BIOLOGICAL

SIF001 intravenous infusion every two weeks

SIF001 10-20mg/kg IV

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)):
• 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.

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• Suninflam Inc: lead

Study Sites (2)

Accel Research sites network

DeLand, Florida, 32720, United States

RECRUITING

Quest Research Institute

Farmington Hills, Michigan, 48334, United States

RECRUITING

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Dongxu Sun, PhD

CONTACT

6507850225; dsun@suninflam.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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 an ascending dose of 20mg/kg. A cohort of epilepsy patients will be added to stage 2.

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: July 4, 2025
• Study Start: June 16, 2025
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): March 15, 2027
• Last Updated: July 4, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)