Phase 1 Single Ascending Dose Safety 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. 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.

Inclusion criteria

• 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 criteria

• 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