A Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of NM-101
Phase 1, double-blind, placebo-controlled, single-centre, single ascending dose escalation study to assess safety and tolerability of a monoclonal antibody, NM-101 in healthy volunteer subject and multiple system atrophy (MSA) patients.
• Male Healthy subjects, 18 to 60 years of age and in good health with no clinically significant abnormality identified on the medical history, physical examination or laboratory evaluation at screening
• Body weight≥ 45kg and body mass index between 18 - 30 kg/m2
• Normal blood pressure (systolic \>90 and \<140 mmHg, diastolic \>40 and \<90mmHg) and pulse rate 40-100bpm at screening visit. Blood pressure and pulse are measured after 3 minutes in supine position
• Baseline QTc must be \<450msec for men and \<470msec for women
• Normal 12-lead electrocardiogram at screening
• No clinically significant abnormal laboratory test values at screening
• No clinically significant findings on the clinical neurological and ophthalmic examinations at screening and at baseline
• Good venous access in both arms
• Willing to consent to participate in study prior to study specific screening procedures with the understanding that the subject has the right to withdraw from the study at any time without prejudice
⁃ Female subject who is surgically sterile, is postmenopausal, or agrees to use a highly effective method of birth control (2 methods strongly recommended) during the study and for 6 months after the dosing of NM-101.