Study to Evaluate the Potential Effects of KH-001 on Intravaginal Ejaculatory Latency Time (IELT), Patient-Reported Outcomes, and Safety in Men With Lifelong Premature Ejaculation (LPE)

Exclusion Criteria

• •1. IELT \>1 minute on more than 25% of attempts during the run-in period.
• •2. Fewer than 4 intercourse attempts during the run-in period.
• •3. Self-rated control of ejaculation as fair, good, or very good on the PEP.
• •4. Low personal distress ("not at all" or "a little bit") on the PEP.
• •5. Erectile dysfunction (IIEF Questions 1-5 sum score \<21).
• •6. Significant anatomical penile deformities or history of penile surgery affecting erection.
• •7. History of other forms of sexual dysfunction.
• •8. Untreated or unstable thyroid dysfunction.
• •9. Recent use (within 4 weeks) of SSRIs, SNRIs, PDE5 inhibitors, MAO inhibitors, alpha blockers, 5-alpha reductase inhibitors, topical anesthetics, or tramadol.
• •10. History of sexual dysfunction treatments like Botox for PE in the past 6 months.
• •11. Active or uncontrolled sexually transmitted infections.
• •12. Severe psychiatric disorders, major depression, or suicidal ideation.
• •13. Clinically significant laboratory abnormalities or cardiovascular risk factors.
• •14. Positive drug screen (unless explained by prescription use).
• •15. Positive for HIV, Hepatitis B, or Hepatitis C.
• •16. Planned major surgery during study period.
• •17. BMI outside 18.0-35.0 kg/m² or weight \<50 kg.