Evaluation of quantitative sensory testing (QST) using subcutaneous administration of single escalating doses of halneuron® (tetrodotoxin (TTX)) for injection in healthy volunteers

eiden University Medical Center0 sites25 target enrollmentMay 12, 2023

Conditionspain Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: pain
Sponsor: eiden University Medical Center
Enrollment: 25
Status: Active, Not Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

May 12, 2023

End Date

February 26, 2024

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

eiden University Medical Center

Eligibility Criteria

Inclusion Criteria

•Willingness to adhere to protocol requirements as evidenced by a valid informed consent form (ICF) duly signed by the subject., Generally healthy males and females, between 18 and 55 years of age (inclusive) with a body mass index (BMI) within 19\-30 kg/m2\., Minimum weight of 50 kg., Normal renal function (creatinine clearance from 80 to 180 mL/min per Cockroft\-Gault equation., Clinical laboratory values within the laboratory's stated normal range. If not within this range, they must be considered not clinically significant by an investigator and must be recorded as such in the CRF., Physical examination within normal limits or considered not clinically significant by an Investigator., Supine blood pressure \= 100/60 mmHg and \= 160/100 mmHg and pulse rate \> 50 bpm and \< 100 bpm after 5 minutes of rest, at screening. Repeat measurements are allowed if initial readings are considered unrepresentative by the PI., Nonsmoker or ex\-smoker (for a minimum of 6 months)., Women of childbearing potential and men must agree to use adequate contraception in the opinion of an investigator (e.g., hormonal or double\-barrier method of birth control; abstinence) during the duration of study participation.

Exclusion Criteria

•Significant history of hypersensitivity to fish or tetrodotoxin or any related products., History of seizure disorder, concussion, or other clinically significant head or spine injury., Presence or history of significant cardiovascular, hematologic, psychiatric, endocrine, immunologic or dermatologic disease., History of malignancy., History of alcoholism considered excessive in the opinion of an investigator, within 12 months, or routine use of ethanol averaging \> 3 units of alcohol per day., Maintenance therapy with any drug, or significant history of drug dependency, including prescription drug abuse., Any clinically significant illness in the previous 28 days before Day 1 of this study. A significant illness is an illness requiring hospitalization or an event that in the opinion of the Investigator no longer classifies the subject as a healthy volunteer”., Use of Botox (Botulinum Toxin Type A) in the past 3 months., Local or systemic exposure to lidocaine., The use of antidepressants or anticonvulsants with known voltage\-gated sodium channel activity., Participation in another clinical trial with drug or device in the previous 30 days., History of anaphylaxis to a medication, dietary item, or environmental exposure (including bee stings)., Positive for human immunodeficiency virus (HIV) infection., Diagnosed with hepatitis B or hepatitis C virus infection., Females with a positive urine pregnancy test at screening, who are lactating, or at risk of pregnancy (i.e., sexually active with fertile males and not using an adequate form of birth control)., Subjects with loss or donation of 50 mL or more of blood in the previous 28 days before Day 1 of this study, or 500mL or more of blood in the previous 56 days before Day 1 of this study., Any condition which makes a candidate unsuitable for study participation, in the opinion of the PI., History of multiple, clinically significant drug allergies, Presence or history of significant gastrointestinal, liver, or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects., History of an obstructive pulmonary disease including asthma, emphysema, or chronic bronchitis., History or presence of any disorder resulting in clinically significant restrictive pulmonary disease., History or presence of Guillain\-Barre syndrome, multiple sclerosis, myasthenia gravis, muscular dystrophy, or other neuropathy or myopathy., A clinically significant deficiency on the neurological part of the physical exam prior to enrollment., Diagnosis or symptoms suggesting central nervous system (CNS) disorders and peripheral nervous system disorders.