Study to Evaluate Safety and PK of NTM-1634 vs Placebo Administered Intravenously in Healthy Adults

Exclusion Criteria

• •1. History of a chronic medical condition that would either interfere with the accurate assessment of the objectives of the study or increase the risk profile of the subject.
• •* Note: Chronic medical conditions include diabetes; Asthma requiring use of medication in the year before screening; Autoimmune disorder such as lupus, Wegener's, rheumatoid arthritis, thyroid disease; Coronary artery disease; Chronic hypertension; History of malignancy except low-grade (squamous and basal cell) skin cancer thought to be cured; chronic renal, hepatic, pulmonary, or endocrine disease (except previous asthma which has required no treatment for the past year);
• •2. History of severe allergic reaction of any type to medications, bee stings, food, or environmental factors or hypersensitivity or reaction to immunoglobulins.
• •* Note: Severe allergic reaction is defined as any of the following: anaphylaxis, urticaria, or angioedema
• •3. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \>450 milliseconds)
• •4. Clinically significant abnormal electrocardiogram at screening.
• •* Note: Clinically significant abnormal ECG results include: complete left or right bundle branch block; other ventricular conduction block; 2nd degree or 3rd degree atrioventricular (AV) block; sustained ventricular arrhythmia; sustained atrial arrhythmia; two Premature Ventricular Contractions in a row; pattern of ST elevation felt consistent with cardiac ischemia; or any condition deemed clinically significant by a study investigator
• •5. Positive serology results for HIV, HBsAg, or HCV antibodies
• •6. Febrile illness with temperature ≥38°C within 7 days of dosing
• •7. Pregnant or breastfeeding
• •8. Donated blood within 56 days of enrollment
• •9. Known allergic reactions to any of the study product components present in the formulation or in the processing, as listed in the Investigator Brochure
• •10. Treatment with another investigational drug within 28 days of dosing
• •11. Treatment with a monoclonal antibody at any time
• •12. Receipt of antibody (e.g. TIG, VZIG, IVIG, IM gamma globulin) or blood transfusion within 6 months or within 5 half-lives of the specific product given
• •13. Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements
• •14. Use of H1 antihistamines or beta-blockers within 5 days of dosing
• •15. Use of any prohibited medication within 28 days prior to study entry or planned use during the study period
• •* Note: Prohibited medications include immunosuppressives (except Nonsteroidal Anti-Inflammatory Drugs \[NSAIDS\]); immune modulators; oral corticosteroids (topical/intranasal steroids are acceptable); anti-neoplastic agents; any vaccine (licensed or investigational)
• •16. Previous exposure to botulinum toxin, receipt of antibodies against botulinum toxin, or previous treatment with equine antitoxin
• •17. Any previous injection or planned injection within 4 months after enrollment of botulinum toxin for cosmetic reasons, spastic dysphonia, torticollis, or any other reason
• •18. Any specific condition that in the judgment of the investigator precludes participation because it could affect subject safety
• •19. Plans to enroll or is already enrolled in another clinical trial\* that could interfere with safety assessment of the investigational product at any time during the study period
• •* Note: Includes trials that have a study intervention such as a drug, biologic, or device
• •20. Is a study site employee or staff
• •* Note: Site employees or staff include the PIs and sub-investigators or staff who are supervised by the PI or Sub-Investigators
• •21. Systolic blood pressure \>140mm Hg or diastolic blood pressure \>90 mm Hg
• •22. Resting hear rate \<50 or \>100 beats per minute
• •23. Oral temperature ≥ 38°C (100.4°F)