A Phase 1 Study of the Safety and Tolerability of Single and Multiple Doses of ANK-700 in Patients With Relapsing Remitting Multiple Sclerosis

Who is this study for? Patients with Multiple Sclerosis
What treatments are being studied? ANK-700
Status: Completed
Location: See all (15) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

A safety study of ANK-700 in patients with relapsing remitting multiple sclerosis. The study has two parts: Part A - first in human study in which patients receive a single dose of ANK-700 Part B - patients will receive three doses of either ANK-700 or placebo

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• Diagnosed with RRMS per revised McDonald criteria (2017) with an EDSS score ≤ 6.5 at screening

• Neurologically stable with no evidence of relapse within the 28 days before signing the informed consent form (ICF)

• Either not currently receiving disease modifying MS therapy, or currently using fumarate drugs (dimethyl fumarate or diroximel fumarate)

• Patients must use a highly effective method of birth control or are sterile or postmenopausal as confirmed by study Investigator

• Patient has signed and understands the ICF

Locations
United States
Alabama
North Central Neurology
Cullman
Arizona
Barrow Neurological Institute
Phoenix
Colorado
UC Health Neurosciences Center
Aurora
Florida
Aqualane Clinical Research
Naples
University of South Florida - Neurology
Tampa
Kansas
University of Kansas Lander Center on Aging/ Neurology
Kansas City
Louisiana
Ochsner Clinic Foundation
New Orleans
Ohio
Cleveland Clinic
Cleveland
Pennsylvania
Jefferson University Hospitals
Philadelphia
South Carolina
Midlands Neurology & Pain Associates PA
Columbia
Tennessee
Advanced Neurosciences Institute
Franklin
Texas
University of Texas Southwestern
Dallas
University of Texas Health Science Center
Houston
Virginia
MS Center of Greater Washington
Vienna
Washington
MultiCare Health System
Tacoma
Time Frame
Start Date: 2020-11-06
Completion Date: 2024-04-23
Participants
Target number of participants: 34
Treatments
Experimental: ANK-700 SAD Cohort 1, 0.3 mg/kg ANK-700
All enrolled patients will receive one dose of 0.3 mg/kg ANK-700
Experimental: ANK-700 SAD Cohort 2, 1.0 mg/kg ANK-700
All enrolled patients will receive one dose of 1.0 mg/kg ANK-700
Experimental: ANK-700 SAD Cohort 3, 3.0 mg/kg ANK-700
All enrolled patients will receive one dose of 3.0 mg/kg ANK-700
Experimental: MAD Cohort 4 0.3 mg/kg ANK-700 or Placebo
All enrolled patients will receive three doses of 0.3 mg/kg ANK-700 or placebo
Experimental: MAD Cohort 5 1.0 mg/kg ANK-700 or placebo
All enrolled patients will receive three doses of 1.0 mg/kg ANK-700 or placebo
Sponsors
Leads: Anokion SA

This content was sourced from clinicaltrials.gov