A Phase I, sequential group, randomized, double-blind, placebo-controlled study to assess the tolerability and safety of escalating doses of oral laquinimod administered daily in subjects with relapsing remitting multiple sclerosis (RRMS)

INTERVENTION: Product Name: Laquinimod Capsules 0.6 mg Product Code: TV‐5600 Pharmaceutical Form: Capsule, hard INN or Proposed INN: laquinimod CAS Number: 248282‐07‐7 Current Sponsor code: TV‐5600 Other descriptive name: ABR‐215062 sodium salt Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.6‐ Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Product Name: Laquinimod Capsules 0.3 mg Product Code: TV‐5600 Pharmaceutical Form: Capsule, hard INN or Proposed INN: laquinimod CAS Number: 248282‐07‐7 Current Sponsor code: TV‐5600 Other descriptive name: ABR‐215062 sodium salt Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.3‐ Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use CONDITION: Laquinimod is developed for the treatment of relapsing remitting multiple sclerosis (RRMS). This study is planned to assess the tolerability and safety of escalating doses of oral laquinimod administered daily in subjects with RRMS. ; MedDRA version: 15.1 Level: PT Classification code 10063399 Term: Relapsing‐remitting multiple sclerosis System Organ Class: 10029205 ‐ Nervous system disorders Therapeutic area: Diseases [C] ‐ Nervous System Diseases [C10] PRIMARY OUTCOME: Main Objective: This study is aimed to assess the safety and tolerability profile of ascending doses; of laquinimod administered daily in subjects with RRMS, and is safety oriented in; nature; therefore, no formal hypothesis testing is planned. Primary end point(s): There is no primary endpoint in this study.; ; This study is aimed to assess the safety and tolerability profile of ascending doses; of laquinimod administered daily in subjects with RRMS, and is safety oriented in; nature; therefore, no formal hypothesis testing is planned. Secondary Objective: Pharmacokinetic assessment.; The relationship between tolerability and safety measures and exposure may be assessed as deemed appropriate. Timepoint(s) of evaluation of this end point: There is no primary endpoint in this study. SECONDARY OUTCOME: Secondary end point(s): This study is aimed to assess the safety and tolerability profile of ascending doses ; of laquinimod administered daily in subjects with RRMS, and is safety oriented in ; nature; therefore, no formal hypothesis testing is planned. Timepoint(s) of evaluation of this end point: This study is aimed to assess the safety and tolerability profile of ascending doses ; of laquinimod administered daily in subjects with RRMS, and is safety oriented in ; nature; therefore, no formal hypothesis testing is planned. INCLUSION CRITERIA: 1. Subjects must have a confirmed and documented diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS), as defined by the Revised McDonald criteria [Ann Neurol 2005: 58:840‐846]. 2. Subjects must have had experienced at least one documented relapse in the 3 years prior to screening. 3. Subjects must be ambulatory with an EDSS score of 0‐5.5 at screening. 4. Subjects must be between 18 and 55 years of age, inclusive. 5. Subjects must be relapse‐free and in a stable neurological condition at least 30 days prior to screening. 6. Women of child‐bearing potential must practice a highly effective method of birth control [acceptable methods of birth control in this study include: surgical sterilization, oral contraceptive, contraceptive patch, long‐acting injectable contraceptive, hormonal intrauterine devices or partner's vasectomy. Subjects using a non‐hormonal IUD will be required to use an additio