A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of VS 105

Inclusion criteria

• ✓. Healthy male and female subjects between 18 and 60 years of age (inclusive). Healthy status, as determined by the investigator, will be based on medical and surgical history, as well as a complete physical examination including vital signs, electrocardiogram (ECG), and laboratory test results.
• ✓. A body mass index (BMI) between 18 and 35 kg/m2 (inclusive).
• ✓. Female subjects of childbearing potential must be non pregnant and non lactating, and have a negative serum pregnancy test at Screening and a negative serum or urine pregnancy test on Day 1 (if initial serum human chorionic gonadotropin \[hCG\] test results are indeterminate, follow up testing should be performed). Female subjects of childbearing potential (including perimenopausal women who have had menstrual bleeding within 1 year) must be using a method of birth control considered to be appropriate by the investigator (eg, abstinence, double barrier methods, hormonal contraceptives, or partner with vasectomy) for the entire duration of the trial. Female subjects of childbearing potential must agree to use appropriate birth control from the time of Screening until at least 1 month after their last dose of study drug.
• ✓. Male subjects must either: remain abstinent from intercourse, be sterile, or agree to use a method of birth control considered to be appropriate by the investigator (eg, condom with spermicide) from the time of Screening until 1 month after their last dose of study drug.
• ✓. Non smoker (and no use of other tobacco or nicotine containing products) as documented by history (no nicotine use over the past 6 months) and a negative cotinine test at Screening and Day 1.
• ✓. Capable of understanding the written informed consent form (ICF) and providing signed and witnessed written informed consent, as well as willing and able to comply with protocol requirements.
• ✓. Subject has end stage renal disease and is on a stable (defined as Kt/V ≥ 1.2 on two occasions within 3 months of screening) HD regimen (prescribed at least 3 times/week) for at least 3 months prior to screening.