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

Tonix Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: TNX-201 70 mg; Drug: TNX-201 140 mg; Drug: Racemic isometheptene 70 mg; Drug: Placebo; Drug: TNX-201 35 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02290379

TNX-IS-T101

Details and patient eligibility

About

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

Full 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.

Enrollment: 27 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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27 participants in 5 patient groups, including a placebo group

TNX-201 35 mg

Experimental group

Description:

Drug: TNX-201 35 mg

Treatment:

Drug: TNX-201 35 mg

TNX-201 70 mg

Experimental group

Description:

Drug: TNX-201 70 mg

Treatment:

Drug: TNX-201 70 mg

TNX-201 140 mg

Experimental group

Description:

Drug: TNX-201 140 mg

Treatment:

Drug: TNX-201 140 mg

Racemic isometheptene 70 mg

Active Comparator group

Description:

Comparator: Racemic Isometheptene 70 mg

Treatment:

Drug: Racemic isometheptene 70 mg

Placebo

Placebo Comparator group

Description:

Drug: Placebo

Treatment:

Drug: Placebo