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

Inclusion Criteria:

1. Informed consent understood and signed prior to screening procedures.

2. Assessed by the Investigator to be a healthy male or healthy, non-pregnant,non-lactating female between the ages of 18 and 65 inclusive on the day of dosing.

3. Able and willing to comply and be available for all protocol procedures andfollow-up for the duration of the study.

4. Body Mass Index (BMI) of ≥18.5 and ≤35 kg/m2.

5. Females of child-bearing potential must have a negative serum pregnancy test atscreening and negative urine pregnancy test on Day 1 prior to dosing.

• A woman is considered of childbearing potential unless post-menopausal (≥ 1year without menses) or surgically sterilized via bilateral oophorectomy, orhysterectomy or bilateral tubal ligation.

6. If the subject is female and of childbearing potential, she agrees to practiceabstinence from sexual intercourse with men or use medically effective contraception (methods with a failure rate of < 1% per year when used consistently and correctly)during participation in the study. Acceptable methods include:

• Hormonal contraception including implants, injections or oral

• Two barrier methods, e.g., condom and cervical cap (with spermicide) ordiaphragm (with spermicide)

• Intrauterine device (IUD) or intrauterine system

7. Screening clinical laboratory results within normal ranges or are no greater than aGrade 1 and deemed not clinically significant by Medical Monitor (MM) and PrincipalInvestigator (PI). Any subjects with results that are Grade 2 or above according toAppendix B will be excluded.

• Laboratory values that are outside the range of eligibility but are thought tobe due to an acute condition or due to laboratory error may be repeated once.

8. The urine drug screen is negative.

• For Cohorts 1-3, if a subject has a positive urine drug screen that the PIbelieves is caused by a currently prescribed medication, (except for THC), thePI may enroll the subject if they meet all inclusion criteria, and none of theexclusion criteria.

• For Cohort 4, if a subject has a positive urine drug screen that the PIbelieves is caused by a currently prescribed medication or positive for THC,the PI may enroll the subject if they meet all other inclusion criteria andnone of the exclusion criteria.

9. Breathalyzer test is negative.

10. Available for follow-up for the duration of the study.

11. Agrees not to participate in vigorous activity 2 days prior to dosing and 2 dayspost-dose Day 1 and Day 45 for Cohorts 1-3 and Day 1 for Cohort 4, per Investigatordiscretion.

Exclusion Criteria:

1. History of a chronic medical condition that would either interfere with the accurateassessment of the objectives of the study or increase the risk profile of thesubject.

• Chronic medical conditions include but are not limited to diabetes; Asthmarequiring use of medication in the year before screening; Autoimmune disordersuch as lupus, Wegener's, rheumatoid arthritis, thyroid disease; coronaryartery 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 hasrequired 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 theformulation or in the processing.

4. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of aQTc 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 blockexcept for incomplete RBB; 2nd degree or 3rd degree atrioventricular (AV)block; sustained ventricular arrhythmia; sustained atrial arrhythmia; twoPremature Ventricular Contractions in a row; pattern of ST elevation feltconsistent with cardiac ischemia; or any condition deemed clinicallysignificant by a study investigator.

6. Positive serology results for human immunodeficiency virus (HIV), hepatitis Bsurface antigen (HBsAg), or hepatitis C virus (HCV) antibodies.

7. Febrile illness with temperature ≥38°C within 7 days of dosing. Subjects with acutefebrile illness within 7 days of dosing may be rescreened no earlier than 7 daysfollowing resolution of symptoms.

8. Female subjects that are pregnant or breastfeeding or intending to become pregnantwithin the projected duration of the trial starting from the Screening visit untillast 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 investigationalproduct (IP) within 28 days preceding Day 1 (documented receipt of placebo in aprevious trial would be permissible for trial eligibility)

11. Plans to enroll in another clinical trial that could interfere with safetyassessment of the IP at any time during the study period.

• Includes trials that have a study intervention such as a drug, biologic, ordevice only

12. Treatment with a mAB within 3 months of Day 1.

13. Receipt of antibody (e.g., tetanus immune globulin [TIG], varicella zoster immuneglobulin [VZIG], intravenous immunoglobulin [IVIG], IM gamma globulin) or bloodtransfusion 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 usethat, in the opinion of the Investigator, would interfere with adherence to studyrequirements.

15. Use of H1 antihistamines or beta-blockers within 5 days of dosing Day 1 and Day 45for 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 useduring the study period.

• Note: Prohibited medications include immunosuppressives (except nonsteroidalanti-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 ofbotulinum toxin for cosmetic reasons, spastic dysphonia, torticollis, or any otherreason.

19. Any illness or condition that in the judgment of the Investigator may affect thesafety 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