NCT07051629

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Suninflam Inc · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Epilepsy
• Healthy Volunteer

Interventions

Type	Name	Description
BIOLOGICAL	SIF001	SIF001 intravenous infusion every two weeks
DRUG	Placebo	Placebo

Timeline

• Start date: 2025-06-16
• Primary completion: 2027-01-15
• Completion: 2027-03-15
• First posted: 2025-07-04
• Last updated: 2025-07-04

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study