This is a Phase 1b/2a open-label, dose escalation 3 part-study, 28-day, 90-day or 180 day repeat dose study of YCT-529 in healthy males who have decided to have a vasectomy and are waiting for the procedure and for men who have decided not to father children in the future. The study is aimed at evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics and to assess sexual function and mood.
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The incidence and nature of any adverse events, dose-limiting adverse events and serious adverse adverse events.
Timeframe: For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
Vital signs assessment (heart rate)
Timeframe: For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
Vital signs assessment (blood pressure)
Timeframe: For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
Vital signs assessment (oral temperature)
Timeframe: For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
12-lead ECG assessment (heart rate)
Timeframe: For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
12-lead ECG assessment (QT interval)
Timeframe: For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
12-lead ECG assessment (QTcF Interval)
Timeframe: For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
12-lead ECG assessment (PR Interval)
Timeframe: For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
12-lead ECG assessment (QRS Duration)
Timeframe: For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
Clinical laboratory assessment- Hemoglobin Blood Sample Test
Timeframe: For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
Clinical laboratory assessment- Hematocrit Blood Sample Test
Timeframe: For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
Clinical laboratory assessment- Packed Cell Volume Blood Sample Test
Timeframe: For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
Clinical laboratory assessment- Red Blood Cell Sample Test
Timeframe: For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
Clinical laboratory assessment- Mean Corpuscular Volume Blood Sample Test
Timeframe: For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
Clinical laboratory assessment- Mean Corpuscular Hemoglobin Blood Sample Test
Timeframe: For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
Clinical laboratory assessment- Mean Corpuscular Hemoglobin Concentration Blood Sample Test
Timeframe: For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
Clinical laboratory assessment- Platelet Count Blood Sample Test
Timeframe: For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
Clinical laboratory assessment- White Blood Cell Sample Test
Timeframe: For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
Clinical laboratory assessment- Neutrophil Blood Sample Test
Timeframe: For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
Clinical laboratory assessment- Lymphocyte Blood Sample Test
Timeframe: For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
Clinical laboratory assessment- Monocyte Blood Sample Test
Timeframe: For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
Clinical laboratory assessment- Eosinophil Blood Sample Test
Timeframe: For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
Clinical laboratory assessment- Basophil Blood Sample Test
Timeframe: For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
Clinical laboratory assessment- Coagulation Blood Sample Test
Timeframe: For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
Clinical laboratory assessment- Activated Partial Thromboplastin Time Blood Sample Test
Timeframe: For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
Clinical laboratory assessment- Fibrinogen Blood Sample Test
Timeframe: For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
Clinical laboratory assessment -Sodium Blood Sample Tests
Timeframe: For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
Clinical laboratory assessment- Chloride Blood Sample Test
Timeframe: For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
Clinical laboratory assessment- Potassium Blood Sample Test
Timeframe: For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
Clinical laboratory assessment- Bicarbonate Blood Sample Test
Timeframe: For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
Clinical laboratory assessment- Urea Blood Sample Test
Timeframe: For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
Clinical laboratory assessment -Creatinine Blood Sample Test
Timeframe: For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
Clinical laboratory assessment -Bilirubin (total) Blood Sample Test
Timeframe: For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
Clinical laboratory assessment -Bilirubin (direct) Blood Sample Test
Timeframe: For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
Clinical laboratory assessment -Alkaline Phosphatase Blood Sample Test
Timeframe: For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
Clinical laboratory assessment -Aspartate aminotransferase Blood Sample Test
Timeframe: For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
Clinical laboratory assessment -Alanine aminotransferase Blood Sample Test
Timeframe: For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
Clinical laboratory assessment -Lactate dehydrogenase Blood Sample Test
Timeframe: For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
Clinical laboratory assessment -Creatinine Kinase Blood Sample Test
Timeframe: For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
Clinical laboratory assessment - Gamma glutamyl transferase Blood Sample Test
Timeframe: For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
Clinical laboratory assessment - Troponin Blood Sample Test
Timeframe: For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
Clinical laboratory assessment - Total Protein Blood Sample Test
Timeframe: For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
Clinical laboratory assessment - Albumin Blood Sample Test
Timeframe: For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
Clinical laboratory assessment - Calcium Blood Sample Test
Timeframe: For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
Clinical laboratory assessment - Fasting Glucose Blood Sample Test
Timeframe: For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
Clinical laboratory assessment - Non Fasting Glucose Blood Sample Test
Timeframe: For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
Clinical laboratory assessment - Fasting Triglycerides Blood Sample Test
Timeframe: For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
Clinical laboratory assessment - Total Fasting Cholesterol Blood Sample Test
Timeframe: For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
Clinical laboratory assessment-Bilirubin Urine Sample Test
Timeframe: For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
Clinical laboratory assessment-Urobilinogen Urine Sample Test
Timeframe: For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
Clinical laboratory assessment- Ketones Urine Sample Test
Timeframe: For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
Clinical laboratory assessment- Glucose Urine Sample Test
Timeframe: For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
Clinical laboratory assessment- Protein Urine Sample Test
Timeframe: For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
Clinical laboratory assessment- Blood Urine Sample Test
Timeframe: For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
Clinical laboratory assessment- Nitrites Urine Sample Test
Timeframe: For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
Clinical laboratory assessment- pH Urine Sample Test
Timeframe: For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
Clinical laboratory assessment- Specific Gravity Urine Sample Test
Timeframe: For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
Clinical laboratory assessment- Leukocytes Urine Sample Test
Timeframe: For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
Clinical laboratory assessment- High Sensitivity C- Reactive Protein
Timeframe: For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.