The APD916-001 study is designed primarily to evaluate the safety and tolerability of APD916 when administered as a single dose
This is a Phase 1, randomized, double-blind, placebo-controlled, single-dose escalation study of up to 9 dose cohorts (1, 2, 5, 10, 20, 30, 45, 70 and 90 mg) each comprising 8 subjects (2 to receive placebo, 6 to receive APD916). Each cohort will be assigned to receive a single dose of APD916. After dosing within the first cohort has been completed and safety data review identifies no tolerability issues, and the principal investigator (PI) and Sponsor have agreed that it is safe to proceed, then subjects in the next cohort may be dosed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
72
Community Research
Cincinnati, Ohio, United States
To evaluate the safety and tolerability of single, escalating doses of APD916 when administered to healthy adult subjects
Safety measures to include adverse events, vital signs, 12-lead ECGs, physical examinations, and clinical lab parameters.
Time frame: Single dose
To assess the pharmacokinetic properties of single, escalating doses of APD916
Pharmacokinetic samples (blood and urine) will be collected.
Time frame: Single dose
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