First in Human Study to Assess Safety of VIS649 in Healthy Subjects

Inclusion Criteria

• Subject voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved informed consent form prior to performing any of the Screening Visit procedures and be able to sign and date an appropriate Health Insurance Portability and Accountability Act (HIPAA) authorization form or subject privacy form, if appropriate.
• Male and female subjects between 18 to 55 years of age, inclusive, at the Screening Visit.
• For Japanese subjects: Subject is of Japanese descent as evidenced by verbal confirmation of familial heritage (a subject has all four Japanese grandparents born in Japan).
• For non-Japanese subjects: Subjects must be of non-Asian descent, as evidenced by verbal confirmation that all four grandparents are non-Asian.
• The following applies to female subjects:
• Non-childbearing potential (surgically sterile [hysterectomy or bilateral tubal ligation]) for at least 6 months, or postmenopausal ≥ 1 year, or
• Non-pregnant, non-lactating females of childbearing potential must report prior use (over the 28 days prior to dosing of study drug) of medically acceptable forms of birth control (hormonal contraception, abstinence, diaphragm with spermicide, condom with spermicide or intrauterine device, or partner with vasectomy), with agreement to continue to use a medically acceptable form of birth control (as described) through the end of their participation in the study. Alternatively, a reported history of abstinence beginning at least 28 days prior to study drug dosing, with agreement to continue abstinence through the end of their participation in the study are required. Females of childbearing potential must also have a negative serum human chorionic gonadotropin (hCG) pregnancy test at Screening and a negative urine hCG pregnancy test at Baseline (Day -1). Female subjects must also agree not to donate eggs/bank eggs for the duration of their participation in the study.
• For male, subject and/or his partner must use a highly effective form of contraception (i.e., double-barrier as described above, have had a vasectomy, or have a female partner of non childbearing potential) or agree to abstinence following study drug dosing, through the end of the subject's participation in the study. Male subjects must also agree to not donate sperm for the duration of their participation in the study, following study drug dosing.
• Screening laboratory values must meet the following criteria:
• White blood cells 3,000 12,000/mm3
• Platelets >150,000/mm3
• Hemoglobin >13 gm/dL for male and>11 gm/dL for female
• Estimated glomerular filtration rate >80 mL/min/1.73 m2
• Serum creatinine 750 mg/dL (7.5 g/L)
• Serum Immunoglobulin M (IgM) >55 mg/dL (0.55 g/L)
• Serum IgA >80 mg/dL (0.8 g/L)
• Body mass index (BMI) between 18 and 32 kg/m2, inclusive, at the Screening Visit.
• Healthy, determined by pre-study medical evaluation (medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations), as judged by the Investigator.
• Is willing and able to comply with study restrictions and to remain at the central processing unit (CPU) for the in-patient duration of the study and return for all follow-up outpatient visits.
• QTcF or QTcB 160/100 mmHg or 500 mL or blood within 60 days prior to start of Screening.
• The subject has donated any plasma within 7 days prior to Baseline (Day -1).
• Is an employee of the clinical research team (any Visterra or research site employee), or has a family member who is an employee of these organizations.