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RECRUITINGPHASE1

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

NCT07051629•Suninflam Inc

View on ClinicalTrials.gov

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

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.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Yes

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
+4 more criteria

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)
+13 more criteria

Locations (2)

Accel Research sites network

DeLand, Florida, United States

Quest Research Institute

Farmington Hills, Michigan, United States

Key Dates

Start Date

June 16, 2025

Primary Completion Date

January 15, 2027

Completion Date

March 15, 2027

Last Updated

July 4, 2025

Enrollment

ESTIMATED participants

Conditions

EpilepsyHealthy Volunteer

Interventions

SIF001

BIOLOGICAL

Placebo

DRUG

Contacts

Dongxu Sun, PhD

CONTACT

6507850225 dsun@suninflam.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 4, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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