Comparison Study of Liquid and Lyophilized Formulations of Subcutaneous Tetrodotoxin (TTX) in Healthy Volunteers

Wex Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Tetrodotoxin; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01527734

TTX-CINP-201PK

Details and patient eligibility

About

The study design is a randomized, double-blind, placebo-controlled, parallel-group, dose comparison with a open-label, crossover, formulation comparison.

Enrollment: 44 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Normal renal function

Exclusion criteria

• History of multiple clinically significant drug allergies

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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44 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: placebo

Tetrodotoxin, TTX

Experimental group

Treatment:

Drug: Tetrodotoxin