This is a Phase 1, randomized, double-blind, placebo-controlled multiple-ascending dose (MAD) study designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of PHP-303 in otherwise healthy overweight or obese volunteer subjects. Within each ascending dose cohort, subjects will be randomized in a 4:1 ratio to receive PHP-303 or placebo. The primary objective is to establish the safety and tolerability and maximum tolerated dose (MTD) of orally-administered PHP-303.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
50
Vince & Associates Clinical Research, Inc.
Overland Park, Kansas, United States
Safety and tolerability of multiple oral doses of PHP-303 - Incidence of Adverse Events
Assess the number of patients with adverse events
Time frame: Up to 12 weeks
Safety and tolerability of multiple oral doses of PHP-303 - number of patients with abnormal ECG
Number of patients with clinically significant change from baseline in standard 12 lead ECG parameters
Time frame: Up to 12 weeks
Safety and tolerability of multiple oral doses of PHP-303 - blood pressure
Number of patients with clinically significant change from baseline in systolic and diastolic blood pressure
Time frame: Up to 12 weeks
Safety and tolerability of multiple oral doses of PHP-303 - heart rate
Measured as number of heart beats per minute
Time frame: Up to 12 weeks
Safety and tolerability of multiple oral doses of PHP-303 - body temperature
Measurement of oral body temperature
Time frame: Up to 12 weeks
Safety and tolerability of multiple oral doses of PHP-303 - respiratory rate
Measured by number of breaths per minute
Time frame: Up to 12 weeks
Plasma concentration of multiple oral doses of PHP-303 - AUC
Area under the curve
Time frame: Plasma Up to 12 weeks
Plasma concentration of multiple oral doses of PHP-303 - Cmax
Maximum observed concentration
Time frame: Up to 12 weeks
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Plasma concentration of multiple oral doses of PHP-303 - Tmax
Time to reach maximum measured plasma concentration
Time frame: Up to 12 weeks
Plasma concentration of multiple oral doses of PHP-303 - t1/2
Determination of half-life
Time frame: Up to 12 weeks