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Clinical Trial Summary

The purpose of this study is to assess the safety and tolerability of an oral solution of CDX-6114 when administered as a single dose in healthy volunteers.


Clinical Trial Description

This is a Phase 1, double-blind, placebo-controlled study in approximately 32 healthy volunteers who are 18 to 55 years old. Four cohorts are planned, each consisting of 8 subjects; the cohorts as planned are 0.225, 0.75, 2.25, and 7.5 g in oral solution. Increasing doses of CDX-6114 will be assessed sequentially until the final dose is evaluated or any of the stopping criteria are reached. Subjects will each receive a single dose and then will be followed for a total of 22 days (3 weeks). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03577886
Study type Interventional
Source Codexis Inc.
Contact Peter J Welburn
Phone +61 (0) 409 479 099
Email pwelburn@eigerhealthconsuting.com
Status Recruiting
Phase Phase 1
Start date July 4, 2018
Completion date September 2018

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