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

Part of paid clinical trials in DeLand, Florida.

Sponsor
Suninflam Inc
Study ID
NCT07051629
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • SIF001 — BIOLOGICAL
    SIF001 intravenous infusion every two weeks
  • Placebo — DRUG
    Placebo

Study Details

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

Key Dates

Start date
Jun 16, 2025
Status verified
Jun 2025
Primary completion
Jan 15, 2027
Completion
Mar 15, 2027

Study Design

Enrollment
72 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: SIF001 10-20mg/kg IV
    SIF001 infused intravenously over one hour
  • Placebo Comparator: Placebo
    Placebo infused intravenously over one hour

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 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Accel Research sites networkDeLandFlorida32720
Michael Hoffmann, MD
[email protected]
3867852400
Quest Research InstituteFarmington HillsMichigan48334
Aaron Ellenbogen, DO
[email protected]
2489578940

Find similar trials in DeLand, FL

By condition
Epilepsy
By specialty
NeurologyBrain disorders
By research site
Accel Research sites network· DeLand, FLQuest Research Institute· Farmington Hills, MI

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