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.

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: TNX-201 35 mg; Drug: TNX-201 70 mg; Drug: TNX-201 140 mg; Drug: Racemic isometheptene 70 mg; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female, ≥ 18 and ≤ 55 years of age on the day of randomization. NOTE: At least 6 female subjects need to be randomized in each cohort.
2. Body mass index (BMI) ≥18.5 and ≤33.0
3. Non-tobacco users (no use of tobacco- or nicotine- containing products within 3 months prior to study drug administration)

Exclusion Criteria:

1. Any clinically significant abnormality or clinically significant abnormal laboratory test results found at Screening or Day -1, or a positive test for HBsAg, HCAb, or HIV found at Screening
2. Positive urine drug screen (including alcohol, tetrahydrocannabinol (THC), cocaine, amphetamines, and opiates) or urine cotinine test at Screening or on Day -1
3. Known or suspected hypersensitivity to isometheptene mucate or any excipients used in the formulations.
4. Positive serum pregnancy test at Screening or Day -1
5. Any reason, in the opinion of the Principal Investigator (PI) or the sponsor's Medical Monitor, to prevent the subject from participating in the study
6. Clinically significant ECG abnormalities

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TNX-201 35 mg; Drug: TNX-201 35 mg	Drug: TNX-201 35 mg; Drug: TNX-201 35 mg
Experimental: TNX-201 70 mg; Drug: TNX-201 70 mg	Drug: TNX-201 70 mg; Drug: TNX-201 70 mg
Experimental: TNX-201 140 mg; Drug: TNX-201 140 mg	Drug: TNX-201 140 mg; Drug: TNX-201 140 mg
Active Comparator: Racemic isometheptene 70 mg; Comparator: Racemic Isometheptene 70 mg	Drug: Racemic isometheptene 70 mg; Active Comparator: Racemic isometheptene 70 mg
Placebo Comparator: Placebo; Drug: Placebo	Drug: Placebo; Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Plasma levels of isometheptene or metabolites.	60 minutes pre-dose and multiple timepoints up to 48 hours post-dose
Number of Adverse events	60 minutes pre-dose and multiple timepoints up to 48 hours post-dose

Collaborators and Investigators

• Sponsor: Tonix Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: November 6, 2014
• First Submitted That Met QC Criteria: November 13, 2014
• First Posted (Estimate): November 14, 2014

Study Record Updates

• Last Update Posted (Estimate): May 17, 2016
• Last Update Submitted That Met QC Criteria: May 16, 2016
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: TNX-IS-T101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No