Chronic-kidney Disease Stage 5D on Stable Hemodialysis Clinical Trial
Official title:
A Phase 1, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of VS 105 Following Oral Administration in Healthy and Hemodialysis Subjects
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.
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).
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT01806610 -
Study of Safety and Tolerability of BPS804 in Patients With Late-stage Chronic Kidney Disease
|
Phase 2 |