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Safety and Tolerability of NTRX-07 in Healthy Volunteers

NCT04375436 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2023-11-08

No results posted yet for this study

Summary

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

Conditions

  • Pain, Neuropathic

Interventions

DRUG

NTRX-07-SDD

NTRX-07-SDD for oral administration

Sponsors & Collaborators

  • Integrium

    collaborator INDUSTRY

  • Orange County Research Center

    collaborator OTHER

  • NeuroTherapia, Inc.

    lead INDUSTRY

Principal Investigators

  • Joseph Foss, MD · NeuroTherapia, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-10-10
Primary Completion
2020-05-15
Completion
2020-06-30
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 NCT04375436 on ClinicalTrials.gov