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: Recruiting
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: No
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
Recruiting
Cullman
Arizona
Barrow Neurological Institute
Recruiting
Phoenix
Colorado
UC Health Neurosciences Center
Recruiting
Aurora
Florida
Aqualane Clinical Research
Recruiting
Naples
University of South Florida - Neurology
Recruiting
Tampa
Kansas
University of Kansas Lander Center on Aging/ Neurology
Recruiting
Kansas City
Louisiana
Ochsner Clinic Foundation
Recruiting
New Orleans
Ohio
Cleveland Clinic
Recruiting
Cleveland
Pennsylvania
Jefferson University Hospitals
Recruiting
Philadelphia
South Carolina
First Care Research Center
Recruiting
Columbia
Tennessee
Advanced Neurosciences Institute
Recruiting
Franklin
Texas
University of Texas Southwestern
Recruiting
Dallas
University of Texas Health Science Center
Recruiting
Houston
Virginia
MS Center of Greater Washington
Recruiting
Vienna
Washington
MultiCare Health System
Recruiting
Tacoma
Contact Information
Primary
Anokion SA
clinicaltrials@anokion.com
+1 857-320-6607
Time Frame
Start Date: November 6, 2020
Estimated Completion Date: June 2024
Participants
Target number of participants: 33
Treatments
Experimental: ANK-700 SAD Cohort 1, Dose A
All enrolled patients will receive one dose of ANK-700 Dose A
Experimental: ANK-700 SAD Cohort 2, Dose B
All enrolled patients will receive one dose of ANK-700 Dose B
Experimental: ANK-700 SAD Cohort 3 Dose C
All enrolled patients will receive one dose of ANK-700 Dose C
Experimental: MAD Cohort 4 ANK-700 Dose A or Placebo
All enrolled patients will receive three doses of ANK-700 Dose A or placebo
Experimental: MAD Cohort 5 ANK-700 Dose B or placebo
All enrolled patients will receive three doses of ANK-700 Dose B or placebo
Authors
Sponsors
Leads: Anokion SA

This content was sourced from clinicaltrials.gov

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