Single or Repeat Dose of G03-52-01 in Adult Subjects

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.
• •\- Chronic medical conditions include but are not limited to 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. Known history of severe allergic reaction of any type to medications, bee stings, food, or environmental factors or hypersensitivity or reaction to immunoglobulins.
• •\- Severe allergic reactions are defined as any of the following: anaphylaxis, urticaria, or angioedema.
• •3. Known allergic reactions to any of the study product components present in the formulation or in the processing.
• •4. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \>450 milliseconds).
• •5. Clinically significant abnormal electrocardiogram (ECG) at screening.
• •\- Clinically significant abnormal ECG results include but are not limited to: complete left or right bundle branch block; other ventricular conduction block except for incomplete RBB; 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.
• •6. Positive serology results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies.
• •7. Febrile illness with temperature ≥38°C within 7 days of dosing. Subjects with acute febrile illness within 7 days of dosing may be rescreened no earlier than 7 days following resolution of symptoms.
• •8. Female subjects that are pregnant or breastfeeding or intending to become pregnant within the projected duration of the trial starting from the Screening visit until last dose.
• •9. Donation of blood or blood product within 56 days of enrollment.
• •10. Is currently participating or has participated in a study with an investigational product (IP) within 28 days preceding Day 1 (documented receipt of placebo in a previous trial would be permissible for trial eligibility)
• •11. Plans to enroll in another clinical trial that could interfere with safety assessment of the IP at any time during the study period.
• •\- Includes trials that have a study intervention such as a drug, biologic, or device only
• •12. Treatment with a mAB within 3 months of Day 1.
• •13. Receipt of antibody (e.g., tetanus immune globulin \[TIG\], varicella zoster immune globulin \[VZIG\], intravenous immunoglobulin \[IVIG\], IM gamma globulin) or blood transfusion within 6 months or within 5 half-lives of the specific product given.
• •14. Reported active drug or alcohol or substance abuse/independence or illicit drug use that, in the opinion of the Investigator, would interfere with adherence to study requirements.
• •15. Use of H1 antihistamines or beta-blockers within 5 days of dosing Day 1 and Day 45 for Cohorts 1-3 and Day 1 for Cohort 4 (PRN use could be allowed with MM approval).
• •16. 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.
• •17. Previous exposure to botulinum toxin, receipt of antibodies against botulinum toxin, or previous treatment with equine antitoxin.
• •18. Any previous injection or any planned injection within 4 months after enrollment of botulinum toxin for cosmetic reasons, spastic dysphonia, torticollis, or any other reason.
• •19. Any illness or condition that in the judgment of the Investigator may affect the safety of the subject or the evaluation of any study endpoint.
• •20. Is a study site employee, staff, or close relative as defined.
• •* PIs and Sub-Investigators
• •* Staff who are supervised by the PI, Sub-Investigators
• •* Member of the team conducting this clinical trial
• •* Children, spouse, partners, siblings, and parents of site staff