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Phase 1 Single Ascending Dose Safety Study of TNX-201 Capsules in Healthy Volunteers

NCT02290379 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2016-05-17

No results posted yet for this study

Summary

Single-center, randomized, double-blind, placebo-controlled, single ascending dose, safety and tolerability study of TNX-201 capsules in healthy volunteers.

Conditions

  • Healthy

Interventions

DRUG

TNX-201 35 mg

Drug: TNX-201 35 mg

DRUG

TNX-201 70 mg

Drug: TNX-201 70 mg

DRUG

TNX-201 140 mg

Drug: TNX-201 140 mg

DRUG

Racemic isometheptene 70 mg

Active Comparator: Racemic isometheptene 70 mg

DRUG

Placebo

Drug: Placebo

Sponsors & Collaborators

  • Tonix Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2015-05-31
Completion
2015-06-30

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Drugs

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 NCT02290379 on ClinicalTrials.gov