HealthyPhase 1NCT04171115
Study to Evaluate Safety and PK of a Single IM Dose of G03-52-01 vs Placebo in Adult Subjects
A Phase 1 study testing G03-52-01 in people with Healthy, run by Alachua Government Services, Inc. at 1 site in United States.
Trial summary
A Phase 1, randomized, double-blind, placebo-controlled dose escalation trial of four dose cohorts of 10 subjects (1: 10mg, 2: 25mg, 3: 50mg, 4: 100mg). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- G03-52-01
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2020to 5 Apr 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Informed consent understood and signed
- Healthy male or healthy, non-pregnant, non-lactating female
- Willingness to comply and be available for all protocol procedures
- Between 18 and 45 years of age on the day of IM injection
- Body Mass Index (BMI) of ≥18.5 and ≤35 kg/m2
- If the subject is female and of childbearing potential, she has a negative serum pregnancy test at screening and negative urine test within 24 hours prior to IM injection
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- Note: 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 or successful Essure placement with documented confirmation test at least 3 months after the procedure.
- If the subject is female and of childbearing potential, she agrees to practice abstinence from sexual intercourse with men or use acceptable contraception during participation in the study
- Note: Acceptable contraception methods are restricted to effective devices (Intrauterine Contraceptive Devices)
- The hemoglobin, platelet count, white blood cell count and absolute neutrophil count are not below the LLN and ≤ULN x 10%
- Abnormalities in mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), red cell distribution width (RDW), mean platelet volume (MPV), and nucleated red blood cell count (NRBC CT), which are included in a complete blood count with differential, will not be exclusions.
- The urine dipstick results on protein, glucose and blood are negative or trace
- Note: Menstruating females failing inclusion criteria due to a positive blood on urine dipstick may be retested following cessation of menses.
- Note: When a urine dipstick is more than trace positive for blood (whether a menstruating female or other subjects), that subject would not be excluded if the urine microscopic exam shows <5 rbcs/hpf.
- Chemistry screening laboratory tests as outlined in Section 7.5.1.4 are in the normal reference range
- Note: The following exceptions to laboratory normal reference ranges are allowed: Creatinine, Blood Urea Nitrogen (BUN), total bilirubin, AST, ALT, lipase, amylase, Prothrombin Time (PT), Partial Thromboplastin Time (PTT) below the lower limit of normal (LLN); CK less than 400U/L; Glucose, potassium, total protein, and alkaline phosphatase with a toxicity grade of 1 is allowable; albumin above the upper limit of normal (ULN).
- 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
- Breathalyzer test is negative
- Available for follow-up for the duration of the study
- Agrees not to participate in vigorous activity 72 hours prior to dosing through day 15 post dosing
Who cannot join
- 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.
- Note: Chronic medical conditions include but 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);
- History of severe allergic reaction of any type to medications, bee stings, food, or environmental factors or hypersensitivity or reaction to immunoglobulins.
- Note: Severe allergic reaction is defined as any of the following: anaphylaxis, urticaria, or angioedema
- A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 milliseconds)
- Clinically significant abnormal electrocardiogram at screening.
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- Note: Clinically significant abnormal ECG results include but not limited to: complete left or right bundle branch block; other ventricular conduction block; 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 HIV, HBsAg, or HCV antibodies
- Febrile illness with temperature ≥38°C within 7 days of dosing
- Pregnant or breastfeeding
- Donated blood within 56 days of enrollment
- Known allergic reactions to any of the study product components present in the formulation or in the processing, as listed in the Investigator Brochure
- Treatment with another investigational drug within 28 days of dosing
- Treatment with a monoclonal antibody within 3 months of enrollment.
- Receipt of antibody (e.g. TIG, VZIG, IVIG, IM gamma globulin) or blood transfusion within 6 months or within 5 half-lives of the specific product given
- Active drug or alcohol use or dependence 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
- 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; any vaccine (licensed or investigational). Subjects will be eligible to receive any authorized COVID-19 vaccine after they complete Study Day 8
- Previous exposure to botulinum toxin, receipt of antibodies against botulinum toxin, or previous treatment with equine antitoxin
- Any previous injection or planned injection within 4 months after enrollment of botulinum toxin for cosmetic reasons, spastic dysphonia, torticollis, or any other reason
- Any specific condition that in the judgment of the investigator precludes participation because it could affect subject safety
- Plans to enroll or is already enrolled in another clinical trial* that could interfere with safety assessment of the investigational product at any time during the study period
- Note: Includes trials that have a study intervention such as a drug, biologic, or device
- Is a study site employee or staff
- Note: Site employees or staff include the PIs and sub-investigators or staff who are supervised by the PI or Sub-Investigators
- Systolic blood pressure >140mm Hg or diastolic blood pressure >90 mm Hg
- Resting hear rate <50 or >100 beats per minute
- Oral temperature ≥ 38°C (100.4°F)
- Subjects with NX02 antibody levels present at screening will be excluded from Cohort 4.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Dose Escalation Study to Evaluate the Safety and Pharmacokinetics of a Single IM Dose of G03-52-01 vs Placebo in Adult Subjects
A Phase 1, randomized, double-blind, placebo-controlled dose escalation trial of four dose cohorts of 10 subjects (1: 10mg, 2: 25mg, 3: 50mg, 4: 100mg).
Read the detailed description
A Phase 1, randomized, double-blind, placebo-controlled dose escalation trial of four dose cohorts of 10 subjects (1: 10mg, 2: 25mg, 3: 50mg, 4: 100mg). Dose escalation will not occur until safety data through Day 8 is reviewed by the Safety Review Committee (SRC). The study will consist of a twenty-eight day screening period, 12-hour clinic stay, and 120-day (Cohorts 1-3) or 180-day (Cohort 4) outpatient follow-up. The primary objective of this study is to assess the safety and tolerability of escalating doses of G03-52-01 administered intramuscularly (IM) in healthy adult subjects. The secondary objectives are to evaluate the pharmacokinetics (PK) and immunogenicity of escalating IM doses of G03-52-01.
- Conditions
- Healthy
- Being tested
- G03-52-01, Placebo
- Keywords
- botulinum toxin, botulism
- Medical subject headings
- Botulism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G03-52-01Drug
G03-52-01 administered intramuscularly
PlaceboDrug
Placebo administered intramuscularly
| Study group | Role | What they receive |
|---|---|---|
| 10mg of G03-52-01 | Experimental | 8 subjects randomized to 10 mg of G03-52-01 and 2 subjects randomized to placebo Receives: Drug: G03-52-01; Drug: Placebo |
| 25mg of G03-52-01 | Experimental | 8 subjects randomized to 25 mg of G03-52-01 and 2 subjects randomized to placebo Receives: Drug: G03-52-01; Drug: Placebo |
| 50 mg of G03-52-01 | Experimental | 8 subjects randomized to 50 mg of G03-52-01 and 2 subjects randomized to placebo Receives: Drug: G03-52-01; Drug: Placebo |
| 100 mg of G03-52-01 | Experimental | 8 subjects randomized to 100 mg of G03-52-01 and 2 subjects randomized to placebo Receives: Drug: G03-52-01; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Occurrence of Serious Adverse Events (SAE) Following Administration of G03-52-01 to the Final Follow-up Visit.
Determine number of SAEs after dosing (Cohorts 1-3)
Measured: day 0 to day 120
The Occurrence of Serious Adverse Events (SAE) Following Administration of G03-52-01 to the Final Follow-up Visit.
Determine number of SAEs after dosing (Cohort 4)
Measured: day 0 to day 180
The Occurrence of Adverse Events (AE) Following Administration of G03-52-01 to the Final Follow-up Visit
Determine number of AEs after dosing (Cohorts 1-3)
Measured: day 0 to day 120
The Occurrence of Adverse Events (AE) Following Administration of G03-52-01 to the Final Follow-up Visit
Determine number of AEs after dosing (Cohort 4)
Measured: day 0 to day 180
The Occurrence of Changes From Baseline in Physical Examination, Vital Signs and Clinical Safety Laboratory Values Following Administration of G03-52-01 to the Final Follow-up Visit.
Determine number of changes from baseline (Cohorts 1-3)
Measured: day 0 to day 120
The Occurrence of Changes From Baseline in Physical Examination, Vital Signs and Clinical Safety Laboratory Values Following Administration of G03-52-01 to the Final Follow-up Visit.
Determine number of changes from baseline (Cohort 4)
Measured: day 0 to day 180
Secondary outcomes (26)
Serotype A Peak Plasma Concentration (Cmax)
MNA assessment of PD (Cohorts 1-3)
Measured: pre-dose, days 4, 30, 60, 90, and 120
Serotype A Peak Plasma Concentration (Cmax)
MNA assessment of PD (Cohort 4)
Measured: pre-dose, 2 hours post-dose, days 4, 30, 45, 60, 90, and 120
Serotype B Peak Plasma Concentration (Cmax)
MNA assessment of PD (Cohorts 1-3)
Measured: pre-dose, days 4, 30, 60, 90, and 120
Serotype B Peak Plasma Concentration (Cmax)
MNA assessment of PD (Cohort 4)
Measured: pre-dose, 2 hours post-dose, days 4, 30, 45, 60, 90, and 120
Serotype A Time to Achieve Peak Concentration of the Drug After Administration (Tmax)
MNA assessment of PD (Cohorts 1-3)
Measured: pre-dose, days 4, 30, 60, 90, and 120
Serotype A Time to Achieve Peak Concentration of the Drug After Administration (Tmax)
MNA assessment of PD (Cohort 4)
Measured: pre-dose, 2 hours post-dose, days 4, 30, 45, 60, 90, and 120
Serotype B Time to Achieve Peak Concentration of the Drug After Administration (Tmax)
MNA assessment of PD (Cohorts 1-3)
Measured: pre-dose, days 4, 30, 60, 90, and 120
Serotype B Time to Achieve Peak Concentration of the Drug After Administration (Tmax)
MNA assessment of PD (Cohort 4)
Measured: pre-dose, 2 hours post-dose, days 4, 30, 45, 60, 90, and 120
Serotype A Area Under the Plasma Concentration Versus Time Curve (AUC)
MNA assessment of PD (Cohorts 1-3)
Measured: pre-dose, days 4, 30, 60, 90, and 120
Serotype A Area Under the Plasma Concentration Versus Time Curve (AUC)
MNA assessment of PD (Cohort 4)
Measured: pre-dose, 2 hours post-dose, days 4, 30, 45, 60, 90, and 120
Serotype B Area Under the Plasma Concentration Versus Time Curve (AUC)
MNA assessment of PD (Cohorts 1-3)
Measured: pre-dose, days 4, 30, 60, 90, and 120
Serotype B Area Under the Plasma Concentration Versus Time Curve (AUC)
MNA assessment of PD (Cohort 4)
Measured: pre-dose, 2 hours post-dose, days 4, 30, 45, 60, 90, and 120
Anti-BoNT A Peak Plasma Concentration (Cmax)
ELISA/ECLA assessment of PK (Cohorts 1-3)
Measured: pre-injection, 2, 4, 8, 24, 48, and 72 hours post injection, and on days 4, 8, 15, 30, 45, 60, 90, and 120
Anti-BoNT A Peak Plasma Concentration (Cmax)
ELISA/ECLA assessment of PK (Cohort 4)
Measured: pre-injection, 6 hours post injection, and on days 1, 2, 4, 8, 15, 30, 45, 60, 90, 120, and 180
Anti-BoNT B Peak Plasma Concentration (Cmax)
ELISA/ECLA assessment of PK (Cohort 4)
Measured: pre-injection, 6 hours post injection, and on days 1, 2, 4, 8, 15, 30, 45, 60, 90, 120, and 180
Anti-BoNT B Peak Plasma Concentration (Cmax)
ELISA/ECLA assessment of PK (Cohorts 1-3)
Measured: pre-injection, 2,4, 8, 24, 48, and 72 hours post injection, and on days 4, 8, 15, 30, 45, 60, 90, and 120
Anti-BoNT A Time to Achieve Peak Concentration of the Drug After Administration (Tmax)
ELISA/ECLA assessment of PK (Cohorts 1-3)
Measured: pre-injection, 2, 4, 8, 24, 48, and 72 hours post injection, and on days 4, 8, 15, 30, 45, 60, 90, and 120
Anti-BoNT A Time to Achieve Peak Concentration of the Drug After Administration (Tmax)
ELISA/ECLA assessment of PK (Cohort 4)
Measured: pre-injection, 6 hours post injection, and on days 1, 2, 4, 8, 15, 30, 45, 60, 90, 120, and 180
Anti-BoNT B Time to Achieve Peak Concentration of the Drug After Administration (Tmax)
ELISA/ECLA assessment of PK (Cohorts 1-3)
Measured: pre-injection, 2, 4, 8, 24, 48, and 72 hours post injection, and on days 4, 8, 15, 30, 45, 60, 90, and 120
Anti-BoNT B Time to Achieve Peak Concentration of the Drug After Administration (Tmax)
ELISA/ECLA assessment of PK (Cohort 4)
Measured: pre-injection, 6 hours post injection, and on days 1, 2, 4, 8, 15, 30, 45, 60, 90, 120, and 180
Anti-BoNT A Area Under the Plasma Concentration Versus Time Curve (AUC)
ELISA/ECLA assessment of PK (Cohorts 1-3)
Measured: pre-injection, 2, 4, 8, 24, 48, and 72 hours post injection, and on days 4, 8, 15, 30, 45, 60, 90, and 120
Anti-BoNT A Area Under the Plasma Concentration Versus Time Curve (AUC)
ELISA/ECLA assessment of PK (Cohort 4)
Measured: pre-injection, 6 hours post injection, and on days 1, 2, 4, 8, 15, 30, 45, 60, 90, 120, and 180
Anti-BoNT B Area Under the Plasma Concentration Versus Time Curve (AUC)
ELISA/ECLA assessment of PK (Cohort 1-3)
Measured: pre-injection, 2, 4, 8, 24, 48, and 72 hours post injection and on days 4, 8, 15, 30, 45, 60, 90, and 120
Anti-BoNT B Area Under the Plasma Concentration Versus Time Curve (AUC)
ELISA/ECLA assessment of PK (Cohort 4)
Measured: pre-injection, 6 hours post injection, and on days 1, 2, 4, 8, 15, 30, 45, 60, 90, 120, and 180
Anti-drug Antibodies (ADA)
To assess the number of participants with positive anti-drug antibody levels (Cohorts 1-3)
Measured: pre-dose, days 15, 30, 45, 60, 90, and 120
Anti-drug Antibodies (ADA)
To assess the number of participants with positive anti-drug antibody levels (Cohort 4)
Measured: pre-dose, days 45, 60, 90, 120, and 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start1 Jun 2020
- Primary completion20 Aug 2022
- Study completion5 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- dose escalation trial of four dose cohorts of 10 subjects (A: 10mg, B: 25mg, C: 50mg, D: 100 mg)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alachua Government Services, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Cassandra Key, MD, Principal investigator, ICON plc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04171115
- Sponsor's protocol ID
- G03-52-01.001
- Status last verified
- Jun 2024
- First submitted
- 15 Nov 2019
- Last updated
- 4 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Dose Escalation Study to Evaluate the Safety and Pharmacokinetics of a Single IM Dose of G03-52-01 vs Placebo in Adult Subjects
- ClinicalTrials.gov ID
- NCT04171115
- Acronym / sponsor ID
- G03-52-01.001
- Conditions
- Healthy
- Keywords
- botulinum toxin, botulism
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Alachua Government Services, Inc.Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 20 Aug 2022 (actual)
- Study completion
- 5 Apr 2023 (actual)
- First posted
- 20 Nov 2019 (actual)
- Results
- Posted 4 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 1, randomized, double-blind, placebo-controlled dose escalation trial of four dose cohorts of 10 subjects (1: 10mg, 2: 25mg, 3: 50mg, 4: 100mg).
Detailed description
A Phase 1, randomized, double-blind, placebo-controlled dose escalation trial of four dose cohorts of 10 subjects (1: 10mg, 2: 25mg, 3: 50mg, 4: 100mg). Dose escalation will not occur until safety data through Day 8 is reviewed by the Safety Review Committee (SRC). The study will consist of a twenty-eight day screening period, 12-hour clinic stay, and 120-day (Cohorts 1-3) or 180-day (Cohort 4) outpatient follow-up. The primary objective of this study is to assess the safety and tolerability of escalating doses of G03-52-01 administered intramuscularly (IM) in healthy adult subjects. The secondary objectives are to evaluate the pharmacokinetics (PK) and immunogenicity of escalating IM doses of G03-52-01.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- dose escalation trial of four dose cohorts of 10 subjects (A: 10mg, B: 25mg, C: 50mg, D: 100 mg)
| Arm | Type | Receives |
|---|---|---|
| 10mg of G03-52-01 | Experimental | Drug: G03-52-01, Drug: Placebo8 subjects randomized to 10 mg of G03-52-01 and 2 subjects randomized to placebo |
| 25mg of G03-52-01 | Experimental | Drug: G03-52-01, Drug: Placebo8 subjects randomized to 25 mg of G03-52-01 and 2 subjects randomized to placebo |
| 50 mg of G03-52-01 | Experimental | Drug: G03-52-01, Drug: Placebo8 subjects randomized to 50 mg of G03-52-01 and 2 subjects randomized to placebo |
| 100 mg of G03-52-01 | Experimental | Drug: G03-52-01, Drug: Placebo8 subjects randomized to 100 mg of G03-52-01 and 2 subjects randomized to placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (21 listed)
- Informed consent understood and signed
- Healthy male or healthy, non-pregnant, non-lactating female
- Willingness to comply and be available for all protocol procedures
- Between 18 and 45 years of age on the day of IM injection
- Body Mass Index (BMI) of ≥18.5 and ≤35 kg/m2
Key exclusion criteria (30 listed)
- 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.
- History of severe allergic reaction of any type to medications, bee stings, food, or environmental factors or hypersensitivity or reaction to immunoglobulins.
- A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 milliseconds)
- Clinically significant abnormal electrocardiogram at screening.
- Positive serology results for HIV, HBsAg, or HCV antibodies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| G03-52-01G03-52-01 administered intramuscularly | Drug | 100 mg of G03-52-01, 10mg of G03-52-01, 25mg of G03-52-01, 50 mg of G03-52-01 |
| PlaceboPlacebo administered intramuscularly | Drug | 100 mg of G03-52-01, 10mg of G03-52-01, 25mg of G03-52-01, 50 mg of G03-52-01 |
Primary outcome
The Occurrence of Serious Adverse Events (SAE) Following Administration of G03-52-01 to the Final Follow-up Visit.
Time frame: day 0 to day 120
Determine number of SAEs after dosing (Cohorts 1-3)
The Occurrence of Serious Adverse Events (SAE) Following Administration of G03-52-01 to the Final Follow-up Visit.
Time frame: day 0 to day 180
Determine number of SAEs after dosing (Cohort 4)
The Occurrence of Adverse Events (AE) Following Administration of G03-52-01 to the Final Follow-up Visit
Time frame: day 0 to day 120
Determine number of AEs after dosing (Cohorts 1-3)
The Occurrence of Adverse Events (AE) Following Administration of G03-52-01 to the Final Follow-up Visit
Time frame: day 0 to day 180
Determine number of AEs after dosing (Cohort 4)
The Occurrence of Changes From Baseline in Physical Examination, Vital Signs and Clinical Safety Laboratory Values Following Administration of G03-52-01 to the Final Follow-up Visit.
Time frame: day 0 to day 120
Determine number of changes from baseline (Cohorts 1-3)
The Occurrence of Changes From Baseline in Physical Examination, Vital Signs and Clinical Safety Laboratory Values Following Administration of G03-52-01 to the Final Follow-up Visit.
Time frame: day 0 to day 180
Determine number of changes from baseline (Cohort 4)
26 secondary outcomes
Serotype A Peak Plasma Concentration (Cmax)
Time frame: pre-dose, days 4, 30, 60, 90, and 120
Serotype A Peak Plasma Concentration (Cmax)
Time frame: pre-dose, 2 hours post-dose, days 4, 30, 45, 60, 90, and 120
Serotype B Peak Plasma Concentration (Cmax)
Time frame: pre-dose, days 4, 30, 60, 90, and 120
Serotype B Peak Plasma Concentration (Cmax)
Time frame: pre-dose, 2 hours post-dose, days 4, 30, 45, 60, 90, and 120
Serotype A Time to Achieve Peak Concentration of the Drug After Administration (Tmax)
Time frame: pre-dose, days 4, 30, 60, 90, and 120
Serotype A Time to Achieve Peak Concentration of the Drug After Administration (Tmax)
Time frame: pre-dose, 2 hours post-dose, days 4, 30, 45, 60, 90, and 120
Serotype B Time to Achieve Peak Concentration of the Drug After Administration (Tmax)
Time frame: pre-dose, days 4, 30, 60, 90, and 120
Serotype B Time to Achieve Peak Concentration of the Drug After Administration (Tmax)
Time frame: pre-dose, 2 hours post-dose, days 4, 30, 45, 60, 90, and 120
Serotype A Area Under the Plasma Concentration Versus Time Curve (AUC)
Time frame: pre-dose, days 4, 30, 60, 90, and 120
Serotype A Area Under the Plasma Concentration Versus Time Curve (AUC)
Time frame: pre-dose, 2 hours post-dose, days 4, 30, 45, 60, 90, and 120
Serotype B Area Under the Plasma Concentration Versus Time Curve (AUC)
Time frame: pre-dose, days 4, 30, 60, 90, and 120
Serotype B Area Under the Plasma Concentration Versus Time Curve (AUC)
Time frame: pre-dose, 2 hours post-dose, days 4, 30, 45, 60, 90, and 120
Anti-BoNT A Peak Plasma Concentration (Cmax)
Time frame: pre-injection, 2, 4, 8, 24, 48, and 72 hours post injection, and on days 4, 8, 15, 30, 45, 60, 90, and 120
Anti-BoNT A Peak Plasma Concentration (Cmax)
Time frame: pre-injection, 6 hours post injection, and on days 1, 2, 4, 8, 15, 30, 45, 60, 90, 120, and 180
Anti-BoNT B Peak Plasma Concentration (Cmax)
Time frame: pre-injection, 6 hours post injection, and on days 1, 2, 4, 8, 15, 30, 45, 60, 90, 120, and 180
Anti-BoNT B Peak Plasma Concentration (Cmax)
Time frame: pre-injection, 2,4, 8, 24, 48, and 72 hours post injection, and on days 4, 8, 15, 30, 45, 60, 90, and 120
Anti-BoNT A Time to Achieve Peak Concentration of the Drug After Administration (Tmax)
Time frame: pre-injection, 2, 4, 8, 24, 48, and 72 hours post injection, and on days 4, 8, 15, 30, 45, 60, 90, and 120
Anti-BoNT A Time to Achieve Peak Concentration of the Drug After Administration (Tmax)
Time frame: pre-injection, 6 hours post injection, and on days 1, 2, 4, 8, 15, 30, 45, 60, 90, 120, and 180
Anti-BoNT B Time to Achieve Peak Concentration of the Drug After Administration (Tmax)
Time frame: pre-injection, 2, 4, 8, 24, 48, and 72 hours post injection, and on days 4, 8, 15, 30, 45, 60, 90, and 120
Anti-BoNT B Time to Achieve Peak Concentration of the Drug After Administration (Tmax)
Time frame: pre-injection, 6 hours post injection, and on days 1, 2, 4, 8, 15, 30, 45, 60, 90, 120, and 180
Anti-BoNT A Area Under the Plasma Concentration Versus Time Curve (AUC)
Time frame: pre-injection, 2, 4, 8, 24, 48, and 72 hours post injection, and on days 4, 8, 15, 30, 45, 60, 90, and 120
Anti-BoNT A Area Under the Plasma Concentration Versus Time Curve (AUC)
Time frame: pre-injection, 6 hours post injection, and on days 1, 2, 4, 8, 15, 30, 45, 60, 90, 120, and 180
Anti-BoNT B Area Under the Plasma Concentration Versus Time Curve (AUC)
Time frame: pre-injection, 2, 4, 8, 24, 48, and 72 hours post injection and on days 4, 8, 15, 30, 45, 60, 90, and 120
Anti-BoNT B Area Under the Plasma Concentration Versus Time Curve (AUC)
Time frame: pre-injection, 6 hours post injection, and on days 1, 2, 4, 8, 15, 30, 45, 60, 90, 120, and 180
Anti-drug Antibodies (ADA)
Time frame: pre-dose, days 15, 30, 45, 60, 90, and 120
Anti-drug Antibodies (ADA)
Time frame: pre-dose, days 45, 60, 90, 120, and 180
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cassandra Key, MD principal investigator
ICON plc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing G03-52-01 in people with Healthy, run by Alachua Government Services, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Occurrence of Serious Adverse Events (SAE) Following Administration of G03-52-01 to the Final Follow-up Visit. (time frame: day 0 to day 120). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2024.