Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
625 participants
INTERVENTIONAL
2022-06-29
2025-02-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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50 mg dose of G03-52-01
150 subjects randomized to 50 mg of G03-52-01
G03-52-01
G03-52-01 administered intramuscularly
100 mg dose of G03-52-01
150 subjects randomized to 100 mg of G03-52-01
G03-52-01
G03-52-01 administered intramuscularly
Placebo
75 subjects randomized to placebo
Placebo
placebo
100 mg dose of G03-52-01 or Placebo
250 subjects randomized to 100 mg of G03-52-01 or placebo
G03-52-01
G03-52-01 administered intramuscularly
Placebo
placebo
Interventions
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G03-52-01
G03-52-01 administered intramuscularly
Placebo
placebo
Eligibility Criteria
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Inclusion Criteria
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 and follow-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 at screening and negative urine pregnancy test on Day 1 prior to dosing.
\- A woman is considered of childbearing potential unless post-menopausal (≥ 1 year without menses) or surgically sterilized via bilateral oophorectomy, or hysterectomy or bilateral tubal ligation.
6. If the subject is female and of childbearing potential, she agrees to practice abstinence 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) or diaphragm (with spermicide)
* Intrauterine device (IUD) or intrauterine system
7. Screening clinical laboratory results within normal ranges or are no greater than a Grade 1 and deemed not clinically significant by Medical Monitor (MM) and Principal Investigator (PI). Any subjects with results that are Grade 2 or above according to Appendix B will be excluded.
\- Laboratory values that are outside the range of eligibility but are thought to be due to an acute condition or due to laboratory error may be repeated once.
8. The urine drug screen is negative.
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 days post-dose Day 1 and Day 45 for Cohorts 1-3 and Day 1 for Cohort 4, per Investigator discretion.
Exclusion Criteria
\- 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
18 Years
65 Years
ALL
Yes
Sponsors
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United States Department of Defense
FED
Alachua Government Services, Inc.
INDUSTRY
Responsible Party
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Locations
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AMR Mobile
Mobile, Alabama, United States
AMR Tempe
Tempe, Arizona, United States
AMR Fort Myers
Fort Myers, Florida, United States
AMR Miami
Miami, Florida, United States
AMR El Dorado
El Dorado, Kansas, United States
AMR Newton
Newton, Kansas, United States
AMR Wichita West
Wichita, Kansas, United States
AMR Wichita East
Wichita, Kansas, United States
AMR Lexington
Lexington, Kentucky, United States
AMR New Orleans
New Orleans, Louisiana, United States
AMR Kansas City
Kansas City, Missouri, United States
AMR Las Vegas
Las Vegas, Nevada, United States
AMR Norman
Norman, Oklahoma, United States
AMR Knoxville West
Knoxville, Tennessee, United States
AMR Norfolk
Norfolk, Virginia, United States
Countries
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Other Identifiers
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G03-52-01-002
Identifier Type: -
Identifier Source: org_study_id
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