The purpose of this study is to evaluate the safety , tolerability, and pharmacokinetics of ascending single dose Fadanafil (XZP-5849)in Chinese healthy adult male subjects. This is the first XZP-5849 clinical study
XZP-5849 is a selective phosphodiesterase (PDE5) inhibitor. The proposed randomized Phase 1 trial is a double-blind, placebo-controlled, single ascending dose study in approximately 66 Chinese healthy adult male subjects. The study consists of 8 cohorts (1 cohort per dose level). Each subject will participate in only one cohort.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
66
Dose escalation for 8 groups: 12.5mg one dose, 25mg one dose, 50mg one dose, 100mg one dose, 200mg one dose, 300mg one dose, 400mg one dose, 500mg one dose
Dose escalation for 8 groups: 12.5mg one dose, 25mg one dose, 50mg one dose, 100mg one dose, 200mg one dose, 300mg one dose, 400mg one dose, 500mg one dose
Haiyan Li
Beijing, Beijing Municipality, China
Electrocardiogram (ECG)
To evaluate subject ECG Changing information
Time frame: Change from Baseline to 1, 2,4,6,8,12,24,36,46 hours after dosing.
Pharmacokinetic Parameter AUC(0-24)
AUC(0-24) of Fadanafile is area under the curve
Time frame: Pre dose and 0.25,0.5,0.75,1,1.5, 2, 2.5, 4, 6,8,12, 24,36 hours after Dosing
Blood Pressure and Heart Rate
To evaluate subject Blood Pressure and Heart Rate Changing information
Time frame: Change from Baseline to 1, 2,4,6,8,12,24,36,46 hours after dosing
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