To characterize the safety and tolerability profile of ascending doses of scopolamine hydrobromide trihydrate (Scopolamine HBT) administered by intramuscular (IM) injection. And characterize the pharmacokinetics (PK) of ascending doses of Scopolamine HBT administered by IM injection
This is a double-blinded, randomized, placebo-controlled, in-clinic, Phase 1, single-dose, IM, sequential dose-escalation study in healthy adults aged 18-55. Healthy volunteers will be assigned to 1 of 5 cohorts of Scopolamine HBT dosage groups: 0.005, 0.007, 0.011, 0.014, or 0.021 mg/kg, or will receive the placebo administered by IM injection to the anterior thigh. In each cohort, 6 to 9 subjects will receive active drug and 2 to 3 subjects will receive placebo. Each cohort will have at least 3 male and 3 female subjects enrolled among the first 8 subjects in the dosing group to ensure that at least 1 male subject and 1 female subject in each dosing group receive active drug. If nonextreme dose-limiting toxicities are observed in any of the cohorts, 4 additional subjects, 3 active and 1 placebo, may be added to each cohort.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
32
Scopolamine Hydrobromide Trihydrate Intramuscular Injection
Pharmaron
Baltimore, Maryland, United States
Determine Degree and Number of Adverse Events Experienced by Subjects.
Safety and tolerability profile of ascending doses of scopolamine hydrobromide trihydrate (Scopolamine HBT) administered by intramuscular (IM) injection
Time frame: 30 Days (+7)
Cmax of Ascending Doses of Scopolamine HBT Administered by IM Injection.
Cmax of ascending doses of Scopolamine HBT administered by IM injection.
Time frame: 30 Days (+7)
Tmax of Ascending Doses of Scopolamine HBT Administered by IM Injection.
Tmax of ascending doses of Scopolamine HBT administered by IM injection.
Time frame: 30 Days (+7)
Apparent Volume of Distribution (mL/kg) of Ascending Doses of Scopolamine HBT Administered by IM Injection.
Apparent Volume of Distribution (mL/kg) of ascending doses of Scopolamine HBT administered by IM injection.
Time frame: 30 Days (+7)
t1/2 (hr) of Ascending Doses of Scopolamine HBT Administered by IM Injection.
t1/2 (hr) of ascending doses of Scopolamine HBT administered by IM injection.
Time frame: 30 Days (+7)
Apparent Clearance (mL/hr/kg) of Ascending Doses of Scopolamine HBT Administered by IM Injection.
Apparent Clearance (mL/hr/kg) of ascending doses of Scopolamine HBT administered by IM injection.
Time frame: 30 Days (+7)
MRT (hr) of Ascending Doses of Scopolamine HBT Administered by IM Injection.
MRT (hr) of ascending doses of Scopolamine HBT administered by IM injection.
Time frame: 30 Days (+7)
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AUClast (hr*ug/mL) of Ascending Doses of Scopolamine HBT Administered by IM Injection.
AUClast (hr\*ug/mL) of ascending doses of Scopolamine HBT administered by IM injection.
Time frame: 30 Days (+7)
AUCinfinity (hr*ug/mL) of Ascending Doses of Scopolamine HBT Administered by IM Injection.
AUCinfinity (hr\*ug/mL) of ascending doses of Scopolamine HBT administered by IM injection.
Time frame: 30 Days (+7)
Cmax/Dose (ug/mL)/(mg/kg) of Ascending Doses of Scopolamine HBT Administered by IM Injection.
Cmax/Dose (ug/mL)/(mg/kg) of ascending doses of Scopolamine HBT administered by IM injection.
Time frame: 30 Days (+7)
AUCinfinity/Dose (hr*ug/mL)/(mg/kg) of Ascending Doses of Scopolamine HBT Administered by IM Injection.
AUCinfinity/Dose (hr\*ug/mL)/(mg/kg) of ascending doses of Scopolamine HBT administered by IM injection.
Time frame: 30 Days (+7)