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

PHASE1CompletedINTERVENTIONAL
Enrollment

69

Participants

Timeline

Start Date

January 24, 2017

Primary Completion Date

March 31, 2018

Study Completion Date

March 31, 2018

Conditions
Chronic-kidney Disease Stage 5D on Stable Hemodialysis
Interventions
DRUG

Single VS-105/placebo to healthy

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.

DRUG

Multiple VS-105/placebo to healthy

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..

DRUG

Multiple VS-105/placebo to HD subjects

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.

Trial Locations (1)

80228

DaVita Clinical Research, Lakewood

All Listed Sponsors
lead

Vidasym, Inc.

INDUSTRY

NCT03043482 - A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of VS 105 | Biotech Hunter | Biotech Hunter