A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of VS 105
Condition: Chronic-kidney Disease Stage 5D on Stable Hemodialysis
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the safety, tolerability, and PK following single and
      multiple ascending dose administration of VS-105 in healthy subjects and patients with
      chronic kidney disease stage 5D (CKD-5D) on hemodialysis.
    

Detailed description: 
      This is a first in human, 3 part, single and multiple ascending dose study in healthy
      subjects and subjects with end stage renal disease (ESRD) requiring hemodialysis (HD). A
      Safety Monitoring Committee (SMC) will evaluate safety data from each dose cohort before
      proceeding with the subsequent cohort. The SMC will also review data from each Part of the
      study before proceeding to the next scheduled Part.

      In Part 1, single ascending doses (SAD) of VS 105 will be administered to approximately 5
      dose cohorts of 8 healthy subjects each. In Part 2, multiple ascending doses (MAD) of VS 105
      will be administered to approximately 3 dose cohorts of 8 healthy subjects each. VS 105 doses
      for MAD cohorts in Part 2 will be determined by the SMC and based on results from Part 1.

      In Part 3, MAD of VS 105 will be administered to approximately 3 successive dose cohorts that
      will each include 4 subjects with ESRD requiring HD. VS 105 doses used in Part 3 will be
      selected by the SMC based on review of safety and/or pharmacokinetic (PK) results from Part 1
      and Part 2.

      Parts 1 & 2 of the study will assess the safety, tolerability, and PK of ascending doses of
      VS 105 to determine the dose range that is safe and well tolerated in healthy subjects.

      Part 3 of the study will assess the safety, tolerability, and PK of various doses of VS 105
      in subjects with ESRD requiring HD (ie, HD subjects), who represent the target population
      with secondary hyperparathyroidism (SHPT).
    

Intervention name(s): Single VS-105/placebo to healthy; Multiple VS-105/placebo to healthy; Multiple VS-105/placebo to HD subjects
Intervention type(s): Drug; Drug; Drug
Intervention description(s): In Part 1, single ascending doses of VS-105 or placebo will be administered to approximately 5 cohorts of 8 healthy subjects in each cohort with 6 receiving active and 2 receiving placebo.; In Part 2, multiple ascending doses of VS 105 or placebo will be administered each morning over 7 consecutive days to approximately 3 cohorts of 8 healthy subjects in each cohort with 6 receiving active and 2 receiving placebo..; In Part 3, multiple ascending doses of VS 105 will be administered over 14 consecutive days to approximately 3 cohorts that will each include 4 hemodialysis subjects with 3 receiving active drug and 1 receiving placebo.
Other intervention name(s): CK15; CK15; CK15
Intervention MeSH terms: Calcitriol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: VS-105; Renal Insufficiency, Chronic; Secondary hyperparathyroidism