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G03-52-01 Safety and Efficacy Study for Healthy Subjects

Phase 2
Waitlist Available
Research Sponsored by Ology Bioservices
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
Awards & highlights

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.

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.Check my eligibility
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.See study design
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 below
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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:
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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.
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I am not pregnant, breastfeeding, nor planning to become pregnant during the trial.
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I have not received any antibody treatments or blood transfusions in the last 6 months.
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I haven't taken any forbidden medications in the last 28 days and won't during the study.
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I have been exposed to or treated with botulinum toxin or related antibodies.
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I have not had monoclonal antibody treatment in the last 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~240 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 240 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 more
Secondary outcome measures
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 more
Other outcome measures
Descriptive statistics of selected PK parameters at all time points tested of the two lots

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

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.

Find a Location

Who is running the clinical trial?

Ology BioservicesLead Sponsor
36 Previous Clinical Trials
31,911 Total Patients Enrolled
United States Department of DefenseFED
875 Previous Clinical Trials
329,361 Total Patients Enrolled

Media Library

G03-52-01 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05348993 — Phase 2
Botox Research Study Groups: 100 mg dose of G03-52-01 or Placebo, 50 mg dose of G03-52-01, 100 mg dose of G03-52-01, Placebo
Botox Clinical Trial 2023: G03-52-01 Highlights & Side Effects. Trial Name: NCT05348993 — Phase 2
G03-52-01 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05348993 — Phase 2
Botox Patient Testimony for trial: Trial Name: NCT05348993 — Phase 2
~253 spots leftby Jan 2026