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).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
40
ICON Early Phase Services
San Antonio, Texas, United States
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: day 0 to day 180
Serotype A Peak Plasma Concentration (Cmax)
MNA assessment of PD (Cohorts 1-3)
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Time frame: pre-dose, days 4, 30, 60, 90, and 120
Serotype A Peak Plasma Concentration (Cmax)
MNA assessment of PD (Cohort 4)
Time frame: 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)
Time frame: pre-dose, days 4, 30, 60, 90, and 120
Serotype B Peak Plasma Concentration (Cmax)
MNA assessment of PD (Cohort 4)
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)
MNA assessment of PD (Cohorts 1-3)
Time frame: 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)
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)
MNA assessment of PD (Cohorts 1-3)
Time frame: 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)
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)
MNA assessment of PD (Cohorts 1-3)
Time frame: 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)
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)
MNA assessment of PD (Cohorts 1-3)
Time frame: 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)
Time frame: 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)
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)
ELISA/ECLA assessment of PK (Cohort 4)
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)
ELISA/ECLA assessment of PK (Cohort 4)
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)
ELISA/ECLA assessment of PK (Cohorts 1-3)
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)
ELISA/ECLA assessment of PK (Cohorts 1-3)
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)
ELISA/ECLA assessment of PK (Cohort 4)
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)
ELISA/ECLA assessment of PK (Cohorts 1-3)
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)
ELISA/ECLA assessment of PK (Cohort 4)
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)
ELISA/ECLA assessment of PK (Cohorts 1-3)
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)
ELISA/ECLA assessment of PK (Cohort 4)
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)
ELISA/ECLA assessment of PK (Cohort 1-3)
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)
ELISA/ECLA assessment of PK (Cohort 4)
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)
To assess the number of participants with positive anti-drug antibody levels (Cohorts 1-3)
Time frame: 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)
Time frame: pre-dose, days 45, 60, 90, 120, and 180