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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: TNX-201 35 mg; Drug: TNX-201 70 mg; Drug: TNX-201 140 mg; Drug: Placebo; Drug: Racemic isometheptene 70 mg

• Registration Number: NCT02290379
• Lead Sponsor: Tonix Pharmaceuticals, Inc.

Brief 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.

Study Timeline

• Status Verified: 2014-11
• Study Start: 2014-11
• Study First Submitted: 2014-11-06
• Study First Submitted QC: 2014-11-13
• Study First Posted: 2014-11-14
• Primary Completion: 2015-05
• Study Completion: 2015-06
• Last Update Submitted: 2016-05-16
• Last Update Posted: 2016-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TNX-201 35 mg	TNX-201 35 mg	Drug: TNX-201 35 mg
TNX-201 70 mg	TNX-201 70 mg	Drug: TNX-201 70 mg
TNX-201 140 mg	TNX-201 140 mg	Drug: TNX-201 140 mg
Placebo	Placebo	Drug: Placebo
Racemic isometheptene 70 mg	Racemic isometheptene 70 mg	Comparator: Racemic Isometheptene 70 mg

Primary Outcome Measures

Name	Time	Method
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