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

NCT03043482 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2019-10-07

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Vidasym, Inc.

    lead INDUSTRY

Principal Investigators

  • Adam Hardies · Davita Clinical Research

  • Robert Williams · Davita Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-24
Primary Completion
2018-03-31
Completion
2018-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03043482 on ClinicalTrials.gov