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G03-52-01 Safety and Efficacy Study for Healthy Subjects
Phase 2
Waitlist Available
Research Sponsored by Resilience Government Services, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Able and willing to comply and be available for all protocol procedures and follow-up for the duration of the study.
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.
Must not have
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
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 visit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 240 days
Summary
This trial is testing a medication called G03-52-01 given as an injection into the muscle. It involves adult participants and will assess the effects of the medication over time.
Who is the study for?
Healthy adults aged 18-65 with a BMI of 18.5 to 35 kg/m2 can join this trial. Women must not be pregnant or breastfeeding and should use effective contraception if of childbearing potential. Participants must have normal lab results, no drug abuse, and agree to avoid vigorous activity around dosing days.
What is being tested?
The study is testing G03-52-01 against a placebo in healthy volunteers. It's a Phase 2 trial where participants are randomly assigned to receive either the test drug or an inactive substance (placebo), but neither they nor the researchers know who gets which one.
What are the potential side effects?
While specific side effects for G03-52-01 aren't listed, common reactions in trials may include injection site discomfort, headache, fatigue, or flu-like symptoms. Placebos typically have no active ingredients but can cause similar mild reactions due to psychological factors.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can attend all study visits and follow the study plan.
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I am a healthy adult between 18 and 65 years old and not pregnant or breastfeeding.
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I am a healthy adult between 18 and 65 years old and not pregnant or breastfeeding if female.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not had, nor plan to have, any botulinum toxin injections for any reason in the 4 months around joining.
Select...
I am not pregnant, breastfeeding, nor planning to become pregnant during the trial.
Select...
I have not received any antibody treatments or blood transfusions in the last 6 months.
Select...
I haven't taken any forbidden medications in the last 28 days and won't during the study.
Select...
I have been exposed to or treated with botulinum toxin or related antibodies.
Select...
I have not had monoclonal antibody treatment in the last 3 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 240 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~240 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Occurrence of AEs following administration of G03-52-01 to the final visit (Cohort 4)
Occurrence of AEs following administration of G03-52-01 to the final visit (Cohorts 1-3)
Occurrence of SAEs following administration of G03-52-01 to the final visit (Cohort 4)
+10 moreSecondary study objectives
Descriptive statistics of selected ADA at all timepoints tested (Cohorts 1-3)
Descriptive statistics of selected ADA at all timepoints tested (Cohorts 4)
Descriptive statistics of selected PD at all timepoints tested (Cohort 4)
+4 moreOther study objectives
Descriptive statistics of selected PK parameters at all time points tested of the two lots
Side effects data
From 2023 Phase 1 trial • 40 Patients • NCT0417111525%
Headache
13%
Diastolic hypertension
13%
Dysuria
13%
Limbs stiffness
13%
Gastroenteritis
13%
Injection site bruising
13%
Light headedness
100%
80%
60%
40%
20%
0%
Study treatment Arm
100 mg of G03-52-01
10mg of G03-52-01
25mg of G03-52-01
Pooled Placebo
50 mg of G03-52-01
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: 50 mg dose of G03-52-01Experimental Treatment1 Intervention
150 subjects randomized to 50 mg of G03-52-01
Group II: 100 mg dose of G03-52-01 or PlaceboExperimental Treatment2 Interventions
250 subjects randomized to 100 mg of G03-52-01 or placebo
Group III: 100 mg dose of G03-52-01Experimental Treatment1 Intervention
150 subjects randomized to 100 mg of G03-52-01
Group IV: PlaceboPlacebo Group1 Intervention
75 subjects randomized to placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
G03-52-01
2020
Completed Phase 1
~40
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Botox (botulinum toxin type A) works by blocking the release of acetylcholine at the neuromuscular junction, preventing muscle contraction. This mechanism helps alleviate symptoms in conditions like myofascial pain, essential tremor, dystonia, and chronic migraines by reducing muscle activity.
For patients, understanding this mechanism is important as it explains the potential benefits and side effects, such as muscle weakness or injection site pain, associated with Botox treatments.
Local treatment of dystonia and spasticity with injections of botulinum-A toxin.Botulinum toxin treatment of myofascial pain: a critical review of the literature.
Local treatment of dystonia and spasticity with injections of botulinum-A toxin.Botulinum toxin treatment of myofascial pain: a critical review of the literature.
Find a Location
Who is running the clinical trial?
Resilience Government Services, Inc.Lead Sponsor
37 Previous Clinical Trials
32,111 Total Patients Enrolled
Ology BioservicesLead Sponsor
36 Previous Clinical Trials
31,911 Total Patients Enrolled
United States Department of DefenseFED
916 Previous Clinical Trials
334,092 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: 100 mg dose of G03-52-01 or Placebo
- Group 2: 50 mg dose of G03-52-01
- Group 3: 100 mg dose of G03-52-01
- Group 4: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- 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.
Botox Patient Testimony for trial: Trial Name: NCT05348993 — Phase 2