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Safety and Tolerability of NTRX-07 in Healthy Volunteers

Pain, Neuropathic Clinical Trial

Official title:
NTRX 07-C101: A Phase 1, Randomized, Placebo-Controlled, Modified Parallel Design Single Ascending Dose Study of NTRX 07 to Assess Safety and Tolerability and Pharmacokinetics in Adult Healthy Volunteers

Clinical Trial Summary

Randomized, placebo-controlled, modified parallel-design single ascending dose (SAD) in adult healthy volunteers (HVs).

Clinical Trial Description

Study NTRX-07-C101 will be conducted with a modified parallel design, incorporating sentinel subjects and a staggered-dosing-days approach. Up to 6 cohorts, A-F, are planned for a total of 48 completing subjects. Each dose cohort will be randomized with 6 subjects receiving active drug and 2 placebo. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04375436
Study type Interventional
Source NeuroTherapia, Inc.
Contact
Status Completed
Phase Phase 1
Start date October 10, 2019
Completion date June 30, 2020
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