Safety, Tolerability, Pharmacokinetics and Efficacy of YHD1044

Phase Ⅰ/Ⅱ Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Efficacy of YHD1044 After Oral Administration in Premature Ejaculation Patients

safety and tolerability, pharmacokinetics/efficacy of an escalating, repeat doses of YHD1044 in premature ejaculation

Inclusion Criteria:

• Patient is in a stable, monogamous sexual relationship with the same woman for at least 6 months and plans to maintain this relationship for the duration of the study
• History of premature ejaculation in the 6 months before study initiation
• History of intravaginal ejaculatory latency time (IELT) of < = 2 minutes in at least half of events
• Premature Ejaculation Diagnostic Tool (PEDT) > =11
• 6 domains of International Index of Erectile Function(IIEF) >= 21
• Patient and partner must agree to attempt sexual intercourse at minimum intervals specified in the protocol
• Patient's partner must have a negative urine pregnancy test at time of screening

Exclusion Criteria:

• Medical history which affects ADME in the past 3 years
• Clinically significant and active disorder in ophthalmic system, gastro-intestine, cardiovascular, respiratory system, endocrine system, autoimmune system or malignant tumor,
• Subjects with clinically significant observations considered as unsuitable based on medical judgment in the physical examination and clinical laboratory tests or a medical history
• History of psychological disease
• Clinically significant allergic disease
• Hypersensitivity to TCA, SSRIs(Clomipramine, sertraline, fluoxetine, dapoxetine)
• Taken dapoxetine within 3 months
• Using other forms of therapy for treatment of PE (behavioral therapy or medications applied to the skin)
• Taken another investigational drug within 1 month
• History of drug abuse