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Purpose

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

Conditions

Eligibility

Eligible Ages
Between 18 Years and 60 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • Diagnosis of primary progressive MS or secondary progressive MS - Uncontrolled or significant medical conditions (including active infection or chronic hepatitis) which, in the opinion of the Investigator, preclude participation - Patients treated with glatiramer acetate, parenteral steroids or adrenocorticotropic hormone, β-interferon, plasma exchange within the 3 months prior to first dose - Patients treated with sphingosine-1-phospate receptor modulators such as fingolimod, ozanimod, or siponimod within 6 months prior to first dose - Patients treated with cytotoxic agents (including, but not limited to, cladribine, mitoxantrone, cyclophosphamide, azathioprine, and methotrexate), laquinimod, teriflunomide, or IV gamma globulin within 12 months prior to first dose - Patients treated with monoclonal antibody therapy (including natalizumab, daclizumab, rituximab, ofatumumab, and ocrelizumab) within 24 months prior to first dose - Patients previously treated with alemtuzumab, total lymphoid irradiation, mesenchymal stem cell or hematopoietic stem cell transplantation, or tolerance-inducing therapies for MS - Contraindication to or inability to undergo gadolinium-enhanced magnetic resonance imaging (MRI) scan - Use of any investigational drug or experimental procedure within previous 6 months that would interfere with the assessment of ANK-700 - Patients who are pregnant or breastfeeding - Patients receiving any vaccination within 28 days prior to first dose - Patient does not agree to limit alcohol intake to 2 drink equivalents or less per day during the study

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
ANK-700 SAD Cohort 1, Dose A 		All enrolled patients will receive one dose of ANK-700 Dose A
  • Drug: ANK-700
    Intravenous (IV) infusion
Experimental
ANK-700 SAD Cohort 2, Dose B 		All enrolled patients will receive one dose of ANK-700 Dose B
  • Drug: ANK-700
    Intravenous (IV) infusion
Experimental
ANK-700 SAD Cohort 3 Dose C 		All enrolled patients will receive one dose of ANK-700 Dose C
  • Drug: ANK-700
    Intravenous (IV) infusion
Experimental
MAD Cohort 4 ANK-700 Dose A or Placebo 		All enrolled patients will receive three doses of ANK-700 Dose A or placebo
  • Drug: ANK-700
    Intravenous (IV) infusion
  • Drug: Placebo
    Intravenous (IV) infusion
Experimental
MAD Cohort 5 ANK-700 Dose B or placebo 		All enrolled patients will receive three doses of ANK-700 Dose B or placebo
  • Drug: ANK-700
    Intravenous (IV) infusion
  • Drug: Placebo
    Intravenous (IV) infusion

More Details

Status
Active, not recruiting
Sponsor
Anokion SA

Study Contact

Detailed Description

Study ANK-700-01 is a Phase 1, FIH study designed to evaluate the safety and tolerability of ANK-700 in patients with relapsing remitting multiple sclerosis (rrms). An overview of the two parts and proposed dose groups is given below: Part A (SAD): Patients will receive a single dose of ANK-700. Part B (MAD): Patients will receive three doses of either ANK-700 or placebo.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.