A study looking at the safety and effect of two kinds of Itolizumab in Normal Healthy Subjects.

INTERVENTION: Itolizumab (Bmab 600) In Stage 1 ‐escalating single doses administered subcutaneously at 0.8, 1.6, 2.4 and 3.2 mg/kg dose levels. In Stage 2 – single dose of 0.8mg/kg administered subcutaneously or intravenous infusion at 0.8 mg/kg dose level over 2 hours Itolizumab (NS0) Stage 2‐ single dose administered as intravenous infusion at 0.8 mg/kg dose level over 2 hours. All doses will be administered in the clinic by study staff. CONDITION: Multiple Sclerosis Psoriasis Rheumatoid arthritis PRIMARY OUTCOME: To compare the pharmacokinetics (PK) of Itolizumab NS0 and Bmab‐600 administered intravenously. ; This will be assessed by collecting and analysing blood samples for drug concentrations at various time points. ; PK parameters include: Cmax, AUC, Tmax, T1/2 To evaluate the safety and tolerance of ascending, single doses of Itolizumab (Bmab 600) administered subcutaneously in normal healthy subjects. ; This will be assessed by monitoring adverse events, physical examination findings including injection site reactions, vital signs, laboratory parameters and electrocardiogram. SECONDARY OUTCOME: To characterize the pharmacokinetic (PK) profile of single doses of Itolizumab (Bmab‐600) administered subcutaneously. ; This will be assessed by collecting and analysing blood samples for Bmab 600 drug concentrations at various time points. ; PK parameters include: Cmax, AUC, Tmax, T1/2 To determine the absolute bioavailability of Itolizumab (Bmab 600) administered subcutaneously. ; This will be assessed by analysing blood samples for drug levels and comparing exposure (AUC) after subcutaneous and intravenous administration. To evaluate immunogenicity of single doses of Itolizumab (Bmab 600) administered subcutaneously. ; This will be assessed by analysing blood samples for anti‐drug antibodies. INCLUSION CRITERIA: 1. Male or female between 18 and 50 years of age (inclusive). 2. Healthy with no clinically significant medical problems. 3. BMI between 18 to 30 kg/m2 with weight between 50 to 100 kg (both inclusive). 4. No history of alcohol or drug abuse (Paracetamol, Barbiturates, Benzodiazepines, Cocaine, Methadone, Amphetamines, Methamphetamines, Opiates, Phencyclidine, Tetrahydrocannabinol (cannabis), Tricyclic Antidepressants). Subjects should be enrolled only after passing the urine drug screen (positive test for paracetamol will be allowed). 5. Non smokers or light smokers (Less than 5 cigarettes per day) by history and planned during study. 6. No history of significant allergic diathesis such as urticaria, angioedema or anaphylaxis. 7. No prior exposure to Itolizumab or other biologicals including monoclonal antibodies, fusion proteins etc. 8. Willing and able to sign written, informed consent.