The Effect of the Dose of PI-2301 on Safety, Tolerability, and Pharmacokinetics in Subjects with the Secondary Progressive Form of Multiple Sclerosis

INTERVENTION: Product Name: PI‐2301 Product Code: CO‐14 Pharmaceutical Form: Solution for injection CAS Number: 1026791‐33‐1 Current Sponsor code: PI‐2301 Other descriptive name: CO‐14 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20‐ Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use CONDITION: Patients with current diagnosis of SP‐MS ; MedDRA version: 9.1 Level: LLT Classification code 10063400 Term: Secondary progressive multiple sclerosis PRIMARY OUTCOME: Main Objective: The primary objective of this study is to evaluate the safety and tolerability of 4 to 6 dose levels of PI 2301 in subjects with SP‐MS when administered weekly for up to 12 weeks Primary end point(s): Safety parameters : ; Safety will be monitored with using physical examinations, vital signs, ECGs, laboratory testing, and AE/SAE assessments. Particular attention will be focused on monitoring for anaphylaxis or hypersensitivity reactions, systemic inflammatory response syndrome (SIRS), and injection site reaction (ISR). ; Secondary Objective: The secondary objectives of this study are to evaluate the pharmacokinetics, effects on immunological/biological markers, magnetic resonance imaging (MRI), and the Expanded Disability Status Scale (EDSS) of 4 to 6 dose levels of PI‐2301 in subjects with SP‐MS when administered weekly for up to 12 weeks INCLUSION CRITERIA: 1. Male or female subjects between the ages of 18 and 60 (inclusive) who have signed an approved, informed consent document. 2. Patients must have a current diagnosis of SP‐MS with duration of diagnosis of at least 1 year and less than 10 years from the baseline examination. 3. Female subjects must not be pregnant or lactating. If of childbearing potential, subjects must decide in conjunction with their physician on a double contraceptive method that they will use in order to avoid being pregnant since at least 14 days before their entry in the study as well as throughout the duration of the study. 4. If a female subject is unable to bear children, this must be documented on the Case Report Form (CRF; e.g., tubal ligation, hysterectomy, postmenopausal). Postmenopausal is defined as a minimum of 1 year since the last menstrual period. 5. Subject must have evidence of MS obtained by MRI (T1 weighted imaging with gadolinium contrast) using a 1.5 T