Status:
COMPLETED
Phase 1 Single Ascending Dose Safety Study of TNX-201 Capsules in Healthy Volunteers
Lead Sponsor:
Tonix Pharmaceuticals, Inc.
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 d...
Eligibility Criteria
Inclusion
- 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.
- Body mass index (BMI) ≥18.5 and ≤33.0
- Non-tobacco users (no use of tobacco- or nicotine- containing products within 3 months prior to study drug administration)
Exclusion
- 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
- Positive urine drug screen (including alcohol, tetrahydrocannabinol (THC), cocaine, amphetamines, and opiates) or urine cotinine test at Screening or on Day -1
- Known or suspected hypersensitivity to isometheptene mucate or any excipients used in the formulations.
- Positive serum pregnancy test at Screening or Day -1
- 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
- Clinically significant ECG abnormalities
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT02290379
Start Date
November 1 2014
End Date
June 1 2015
Last Update
May 17 2016
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