Open Label Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Repeated Daily Oral Dosing of YCT-529 for 28 Days, 90 Days or 180 Days in Healthy Men
Sponsor study identifier
interventional
88
1 country
1
Study Start
September 11, 2024
Actual (reported)Primary Completion
July 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 3, 2024
Actual (reported)August 7, 2024
Actual (reported)September 11, 2024
Actual (reported)July 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The incidence and nature of any adverse events, dose-limiting adverse events and serious adverse adverse events.
Assessment of the number and type of adverse events, dose-limiting adverse events and serious adverse events following dosing.
For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
Vital signs assessment (heart rate)
Changes from pre-dose values (beats per minute)
For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
Vital signs assessment (blood pressure)
Changes from pre-dose values (mm hg)
For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
Open label, dose escalation, 3 part study (Phase 1b includes Part 1; Phase 2a includes Parts 2 and 3).
In Part 1, 4 dosing cohorts and one optional 5th cohort with 4 participants each will be evaluated. In Part 2, up to 5 dosing cohorts and 2 optional cohorts with 4 participants each will be evaluated. Dose levels will be selected based on doses that were deemed safe and well tolerated upon 28-day administration in Part 1 and any previous Part 2 cohorts. In Part 3, 3 dosing cohorts and one optional 4th cohort with 10 participants each will receive doses within the range of doses that were deemed safe and well tolerated in Part 2.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
New Zealand Clinical Research (NZCR)
Grafton, Auckland, 1010, New Zealand
Rohit Katia, MBChB
New Zealand Clinical Research
First Submitted
July 3, 2024
First Posted
August 7, 2024
Study Start
September 11, 2024
Actual (reported)Primary Completion
Phase 1 Study of Dimethandrolone Undecanoate in Healthy Men
Vital signs assessment (oral temperature)
Changes from pre-dose values (temperature in celsius degrees)
For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
12-lead ECG assessment (heart rate)
Changes from pre-dose values (beats per minute)
For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
12-lead ECG assessment (QT interval)
Changes from pre-dose values for QT internal length (msec)
For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
12-lead ECG assessment (QTcF Interval)
Changes from pre-dose values for QTcF interval length (msec)
For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
12-lead ECG assessment (PR Interval)
Changes from pre-dose values for PR interval length (msec)
For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
12-lead ECG assessment (QRS Duration)
Changes from pre-dose values for QRS duration (msec)
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
Change from pre-dose value for hemoglobin (gm/dl)
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
Change from pre-dose value for hematocrit (%)
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
Change from pre-dose value for packed cell volume (%)
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
Change from pre-dose value for red blood cells (g/dL)
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
Change from pre-dose value for mean corpuscular volume (fL)
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
Change from pre-dose value for mean corpuscular hemoglobin (MCH)
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
Change from pre-dose value for mean corpuscular hemoglobin concentration (g/dL)
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
Change from pre-dose value for platelets (microL)
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
Change from pre-dose value for White blood cells (cells/L)
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
Change from pre-dose value for Neutrophils (cells/L)
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
Change from pre-dose value for Lymphocytes (cells/mcL)
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
Change from pre-dose value for Monocytes (cells/L)
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
Change from pre-dose value for Eosinophils (%)
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
Change from pre-dose value for Basophils (%)
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
Changes from pre-dose value for Prothrombin time (seconds)
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
Changes from pre-dose values for Activated partial thromboplastin time (seconds)
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
Changes from pre-dose value for Fibrinogen (mg/dL)
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
Changes from pre-dose value for Sodium (mEq/L)
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
Changes from pre-dose value for Chloride (mmol/L)
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
Changes from pre-dose value for Potassium (mEq/L)
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
Changes from pre-dose value for Bicarbonate (mEq/L)
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
Changes from pre-dose value for Urea mmol/L
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
Changes from pre-dose value for Creatinine (mg/dL)
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
Changes from pre-dose value for Bilirubin (mg/dL)
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
Changes from pre-dose value for Bilirubin, direct only if total bilirubin is elevated (mg/dL)
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
Changes from pre-dose value for Alkaline Phosphatase (U/L)
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
Changes from pre-dose value for Aspartate aminotransferase (U/L)
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
Changes from pre-dose value for Alanine aminotransferase (U/L)
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
Changes from pre-dose value for Lactate dehydrogenase (U/L)
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
Changes from pre-dose value for Creatine kinase for (U/L)
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
Changes from pre-dose value for Gamma glutamyl transferase (U/L)
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
Changes from pre-dose value for Troponin (ng/mL)
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
Changes from pre-dose value for Total Protein (g/dL)
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
Changes from pre-dose value for Albumin (g/dL)
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
Changes from pre-dose value for Calcium (mg/dL)
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
Changes from pre-dose value for Fasting Glucose (mg/dL)
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
Changes from pre-dose value for Non Fasting Glucose (mg/dL)
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
Changes from pre-dose value for Fasting Triglycerides (mg/dL)
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
Changes from pre-dose value for Total Fasting Cholesterol) (mg/dL)
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
Changes from pre-dose values for Bilirubin (mg/dL)
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
Changes from pre-dose value for Urobilinogen (mmol/L)
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
Changes from pre-dose value for Ketones (mmol/L)
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
Changes from pre-dose value for Glucose (mmol/L)
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
Changes from pre-dose values for Protein (mg/dL)
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
Changes from pre-dose value for Blood (RBC/HPF)
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
Changes from pre-dose value for Nitrites (mg/dL)
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
Changes from pre-dose value for pH (pH value)
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
Changes from pre-dose value for Specific Gravity (USG)
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
Changes from pre-dose value for Leukocytes (leukocytes per microscopic field)
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
Changes from pre-dose value for High Sensitivity C- Reactive Protein (mg/L)
For Part 1, from baseline to Day 280 and only in Part 2 from baseline to Day 360.
Plasma PK Parameter of YCT-529 (Area under the curve to Infinity [AUCinf])
Pre-dose to 28 days post last dose in Part 1, and from pre-dose to 30 days post last dose in Parts 2 and 3.
Plasma PK Parameter of YCT-529 (Area under the curve to the last measured concentration [AUC0-t])
Pre-dose to 28 days post last dose in Part 1, and from pre-dose to 30 days post last dose in Parts 2 and 3.
Plasma PK Parameter of YCT-529 (Area under the curve to 24 hours [AUC0-24])
Pre-dose to 28 days post last dose in Part 1, and from pre-dose to 30 days post last dose in Parts 2 and 3.
Plasma PK Parameter of YCT-529 (Time to maximum concentration [Tmax])
Pre-dose to 28 days post last dose in Part 1, and from pre-dose to 30 days post last dose in Parts 2 and 3.
Plasma PK Parameter of YCT-529 (Terminal elimination half life [T1/2])
Pre-dose to 28 days post last dose in Part 1, and from pre-dose to 30 days post last dose in Parts 2 and 3.
Contact the study team to confirm eligibility.
July 31, 2026
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 13, 2026
Record last verified: 2026-02
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Source: ClinicalTrials.gov.
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