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G03-52-01 Safety and Efficacy Study for Healthy Subjects
Study Summary
This trial is testing a new drug to see if it is effective and safe. The trial is comparing the new drug to a placebo, and is double-blind, meaning neither the participants nor the researchers will know who is receiving which until the trial is over.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have not had, nor plan to have, any botulinum toxin injections for any reason in the 4 months around joining.I am not of childbearing potential due to menopause or surgery.I can follow all study requirements and attend all appointments.My positive drug test is due to prescribed medication, and I meet all other study requirements.I am using highly effective birth control or practicing abstinence.I am a woman who can have children and have tested negative for pregnancy.You are female and of child-bearing potential.I can attend all study visits and follow the study plan.You are using hormonal birth control methods like implants, injections, or pills.I am not of childbearing potential due to menopause or sterilization.I don't have chronic conditions that could affect the study or increase my risk.I am not able to become pregnant due to menopause or surgery.I have not had a fever of 38°C or higher in the last 7 days.I am not pregnant, breastfeeding, nor planning to become pregnant during the trial.I agree to use effective birth control or practice abstinence during the study.I have not donated blood in the last 56 days.I have not received any antibody treatments or blood transfusions in the last 6 months.I haven't taken any forbidden medications in the last 28 days and won't during the study.I am a healthy adult between 18 and 65 years old and not pregnant or breastfeeding.My recent lab results are mostly normal or slightly abnormal but not serious.I haven't taken H1 antihistamines or beta-blockers in the last 5 days.I am a healthy adult between 18 and 65 years old and not pregnant or breastfeeding if female.I have been exposed to or treated with botulinum toxin or related antibodies.I have not had monoclonal antibody treatment in the last 3 months.You have had a serious allergic reaction in the past to medications, bee stings, certain foods, or things in the environment. This includes reactions like difficulty breathing, hives, or swelling.Your body mass index (BMI) falls between 18.5 and 35 kg/m2.
- Group 1: 50 mg dose of G03-52-01
- Group 2: 100 mg dose of G03-52-01
- Group 3: Placebo
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does the trial encompass participants aged 70 and above?
"The requirements of this medical trial stipulate that participants must be between the age of 18 and 65. For those under or over these ages, there are 51 and 374 trials respectively open to them."
What is the present sample size of this trial?
"Affirmative. The clinicaltrial.gov website confirms that, as of August 3rd 2022, this trial is actively recruiting participants; it was initially posted on June 29th 2022 and 375 patients need to be recruited from 15 specified medical centres."
Are additional participants being accepted for this clinical experiment?
"Affirmative. According to clinicaltrials.gov, this research was initially posted on June 29th 2022 and has been actively looking for participants ever since. With 15 different sites recruiting individuals, a total of 375 volunteers are needed in order to complete the study."
How many facilities are currently running this clinical trial?
"The current list of trial sites entails AMR Newton in Newton, Alabama; AMR Mobile in Mobile Florida; and AMR Miami in Miami Missouri. Additionally, there are an additional 15 locales where medical professionals have been asked to enroll patients for the study."
Has G03-52-01 been sanctioned by the Food and Drug Administration?
"Our team has determined that G03-52-01 is likely to be safe, as evidenced by the prior clinical data available. This conclusion was corroborated with a score of 2 on our 1 to 3 scale system due its Phase 2 trial status."
What criteria must a person meet to qualify for this medical experiment?
"This clinical trial requires 375 participants aged between 18 and 65 to have been exposed to botulinum toxin. To be eligible, the following criteria must be met: a fully signed informed consent form; BMI of 18.5 - 35 kg/m2; post-menopausal women or surgically sterilized female applicants are welcomed; healthy males and non-pregnant/non-lactating females can apply; availability for all study procedures throughout duration of trial period is mandatory; negative serum pregnancy test at screening, as well as urine pregnancy test on Day 1 before dosing necessary for childbearing potential subjects; two barrier methods such as"
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