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

Completed · Phase 2 · Has a placebo group

Conditions studied: Healthy, Botulinum Toxin

In brief

A Phase 2, randomized, double-blind, placebo-controlled single or repeat dose trial

Key facts

Study ID

NCT05348993

Run by

U.S. Army Medical Research and Development Command

People needed

622

Starts

2022-06-15

Expected to finish

2025-02-18

Last updated by the study team

2026-02-17

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Informed consent understood and signed prior to screening procedures.
• 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.
• Able and willing to comply and be available for all protocol procedures and follow-up for the duration of the study.
• Body Mass Index (BMI) of ≥18.5 and ≤35 kg/m2.
• 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.
• 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
• 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.
• The urine drug screen is negative.
• For Cohorts 1-3, if a subject has a positive urine drug screen that the PI believes is caused by a currently prescribed medication, (except for THC), the PI may enroll the subject if they meet all inclusion criteria, and none of the exclusion criteria.
• For Cohort 4, if a subject has a positive urine drug screen that the PI believes is caused by a currently prescribed medication or positive for THC, the PI may enroll the subject if they meet all other inclusion criteria and none of the exclusion criteria.
• Breathalyzer test is negative.
• Available for follow-up for the duration of the study.
• 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.

You may not qualify if…

• 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).
• 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.
• Known allergic reactions to any of the study product components present in the formulation or in the processing.
• A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 milliseconds).
• 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.
• Positive serology results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies.
• 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.
• 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.
• Donation of blood or blood product within 56 days of enrollment.
• 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)
• 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
• Treatment with a mAB within 3 months of Day 1.
• 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.
• 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.
• 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).
• 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.
• Previous exposure to botulinum toxin, receipt of antibodies against botulinum toxin, or previous treatment with equine antitoxin.
• 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.
• 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.
• Is a study site employee, staff, or close relative as defined.

Where it is running

• 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

Full record on ClinicalTrials.gov

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