NCT02290379

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

A Single-Center, Randomized, Double-blind, Placebo-controlled, Phase 1, Single Ascending Dose Safety, Tolerability, and Pharmacokinetic Study of TNX-201 Capsules in Healthy Volunteers.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Tonix Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

Single-center, randomized, double-blind, placebo-controlled, single ascending dose, safety and tolerability study of TNX-201 capsules in healthy volunteers. Three successive cohorts are planned with doses of TNX-201 capsules, 35 mg, 70 mg, and 140 mg, respectively. Each cohort will consist of 15 subjects, and subjects will be randomly assigned to TNX-201, racemic isometheptene, or placebo capsules.

Conditions

• Healthy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2014-11-01
• Primary completion: 2015-05-01
• Completion: 2015-06-01
• First posted: 2014-11-14
• Last updated: 2016-05-17