Open Label, Dose Escalation, Repeat Dose Study Evaluating YCT-529 in Healthy Males

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

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.

Study Overview

• Status: Recruiting
• Conditions: Male Contraception
• Intervention / Treatment: Drug: YCT-529

Detailed Description

This is a Phase 1b/2a, open label, 28-day, 90-day or 180-day repeat-dose escalation study of YCT-529 in healthy men to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics, and to assess sexual function and mood.

The study consists of 3 parts: a 28-day Phase 1b part (Part 1), a 90-day Phase 2a part (Part 2) and a 180-day Phase 2a part (Part 3). All participants will receive YCT-529.

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. Participants in Parts 1 and 2 may be replaced automatically if prior to any dosing. If a participant is required to be replaced post-dose, the replacement may beapproved at the discretion of Sponsor and PI with the objective of available data in at least 3 evaluable participants per cohort. 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. Participants who discontinue early may be replaced.

• Study Type: Interventional
• Enrollment (Estimated): 88
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Nadja Mannowetz, PhD; Phone Number: 415-233-6970; Email: ClinicalTrial@ychoicetx.com

Study Locations

• New Zealand
  • Auckland
    • Grafton, Auckland, New Zealand, 1010
      • Recruiting
      • New Zealand Clinical Research (NZCR)
      • Contact: Taisha Stowers; Phone Number: 0800 788 3437; Email: Latitude.Auckland@nzcr.co.nz
      • Principal Investigator: Rohit Katial, MBChB

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Participant in good health as confirmed by physical examination, medical history, and clinical laboratory tests.
2. Participant must provide written informed consent.
3. Participant must be willing and able to communicate and participate in the whole study.
4. Participant is 28 to 70 years of age (inclusive) at the time of consent.
5. Participant has decided to have a vasectomy and is waiting for the procedure or participant, in the opinion of the investigator, has made a firm decision not to father children in the future.
6. Participant has a body mass index (BMI) 18.0 to 35.0 kg/m2.
7. Participant has no history of hormonal therapy or 5-alpha reductase inhibitors use in the 90 days prior to the first screening visit.
8. Participant with partner(s) of childbearing potential agrees to use a method of contraception that is highly effective with any partner (i.e., total abstinence or at a minimum, barrier method plus additional method of contraception) during the study until 28 days after the last dose (Day 56 [Part 1] or Day 118 [Parts 2 and 3]). Condom use is required during the course of the study with partner(s) of both childbearing and non-childbearing potential until Day 56 (Part 1) or Day 118 (Parts 2 and 3) to avoid potential secondary transmission of study drug and ensure the safety of the participants' sexual partner(s). Total abstinence from intercourse during the course of the study until Day 56 (Part 1) or Day 118 (Parts 2 and 3) is considered an acceptable form of contraception if this is in line with participant's preferred and/or usual lifestyle. Condom use is not required while practicing total abstinence.
9. Participant will refrain from donating blood or plasma during the study.
10. Participant will not use cannabis or any other recreational drugs for at least 30 days before the Screening visit and during the study. The marijuana/cannabis test can be positive at Screening but needs to be negative at admission (Day -1) for a volunteer to be eligible for inclusion in the study.
11. Part 1: In the opinion of the investigator, participant is able to adhere to the study requirements, restrictions, schedule of assessments, and requirements related to sperm sample collection and maintenance of the sexual activity diary. Parts 2 and 3: In the opinion of the investigator, participant is able to adhere to the study requirements, restrictions, schedule of assessments, and requirements related to semen sample collection and maintenance of the electronic dosing diary.

12. Part 1: Participant providing at least 2 semen samples during the screening period with sperm parameters within at least the 5th percentile of the WHO range of normality (WHO, 2010 and WHO, 2021):

    • 15 million sperm cells/mL
    • 39 million sperm cells/total ejaculate
    • 40% total motility
    • 30% progressive motility Parts 2 and 3: Participant providing 3 semen samples during the screening period with ≥ 15 million sperm cells/mL (at least the 5th percentile of the WHO range of normality [WHO, 2021]).

Exclusion Criteria:

1. Men participating in another clinical study involving an investigational drug within the last 30 days prior to the first dosing or less than 5 elimination half-lives prior to first dosing, whichever is longer.
2. Clinically significant abnormal physical and/or laboratory findings at Screening
3. Abnormal serum chemistry values at screening or admission, that indicate liver or kidney dysfunction or that may be considered clinically significant as determined by the PI, except for bilirubin >24 μmol/L and ALT, AST, GGT and ALP 2-fold above the upper limit of normal. Volunteers with known Gilbert's syndrome will be excluded if total bilirubin is ≥1.5 x ULN.
4. Evidence of renal impairment at screening, as indicated by an estimated eGFR of <80 mL/min/1.73 m2 using the 2021 CKD-EPI Creatinine Equation (https://www.kidney.org/professionals/kdoqi/gfr_calculator) .
5. Use of androgens and selective androgen receptor modulators (SARMs) within 90 days before first screening visit.
6. Volunteers with a body weight < 55 kg.
7. Systolic blood pressure (BP) >140 mmHg (<45 years) or >160 mmHg (≥45 years) and diastolic BP >90 mmHg at screening and admission.
8. Clinically significant abnormal electrocardiogram (ECG) or a duration of corrected QT interval using Bazett's and Fridericia's QT correction methods in ECG (QTc) interval of >450 msec at screening or predose.
9. Known history of androgen deficiency due to hypothalamic-pituitary or testicular disease or multiple endocrine deficiencies.
10. Known history of significant cardiovascular, renal, hepatic (cholecystectomy is not permitted), or prostatic disease. Gilbert's syndrome is allowed (volunteer with known Gilbert's syndrome will be excluded if total bilirubin is ≥1.5 x ULN). If volunteer has elevations only in total bilirubin that are >ULN and <1.5xULN, fractionate bilirubin to identify possible undiagnosed Gilbert's syndrome (i.e., direct bilirubin <35% of the total bilirubin).
11. Current or clinically relevant history of any psychiatric disorder or clinical assessment of significant suicidal risk or risk of self-injury as per the Investigator's judgement.
12. Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients.
13. Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Seasonal allergies (e.g., hay fever) are allowed unless considered clinically significant by the investigator.
14. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) 1 and 2 antibody results at screening visit.
15. Known or suspected alcoholism or drug abuse within the last 2 years that may affect metabolism/transformation of steroid hormones or study treatment compliance.
16. Volunteers who do not have suitable veins for multiple venipunctures/cannulation as assessed by the investigator or delegate at screening.
17. Regular alcohol consumption in males >21 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 units = 125 mL glass of wine, depending on type.
18. Current smokers who have consumed at least 5 cigarettes or equivalent amount of nicotine per week within the last 3 months prior to Screening.
19. Confirmed positive drugs of abuse test result at Screening and admission and/or positive marijuana/cannabis test at admission (Day -1).
20. Participants and volunteers who are taking, or have taken, any prescribed or over-the-counter drug or vitamins/herbal remedies/supplements (other than up to 4 g of paracetamol or up to 3.2 g of ibuprofen per day during the 14 days before IMP administration). COVID-19 vaccines are accepted concomitant medications. Other concomitant medications may be accepted at the discretion of both the PI and the Sponsor. Exceptions may apply, as determined by the investigator, if each of the following criteria are met: medication with a short half-life if the washout is such that no PD activity is expected by the time of dosing with IMP; and if the use of medication does not jeopardize the safety of the trial participant; and if the use of medication is not considered to interfere with the objectives of the study.
21. Male volunteer with pregnant or lactating partner(s).
22. Any site staff member with delegated study responsibilities or a family member of a site staff member with delegated study responsibilities.

23. Any other medical condition that, in the opinion of the investigator, could alter the volunteer's well-being, the study conduct, or the interpretability of the results.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: YCT-529; Open label, dose escalation, 3 part study (Phase 1b includes Part 1; Phase 2a includes Parts 2 and 3).

Drug: YCT-529; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma PK Parameter of YCT-529 (Area under the curve to Infinity [AUCinf])	Plasma PK Parameter as measured by area under the curve from time 0 extrapolated 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])	Plasma PK Parameter as measured by area under the curve from time 0 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])	Plasma PK Parameter as measured by area under the curve from time 0 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])	Plasma PK Parameter as measured by 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])	Plasma PK Parameter as measured by 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.
Plasma PK Parameter of YCT-529 (Lag time [Tlag])	Plasma PK Parameter as measured by lag time [Tlag]	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 (Volume of distribution [Vz/F])	Plasma PK Parameter as measured by apparent volume of distribution [Vz/F]	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 (oral clearance [CL/F])	Plasma PK Parameter as measured by oral clearance [CL/F] of YCT-529	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 (maximum concentration [Cmax])	Plasma PK Parameter as measured by maximum concentration [Cmax]) of YCT-529	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.
Pharmacodynamic parameter of YCT-529, including follicle-stimulating hormone	Changes from pre-dose values of follicle-stimulating hormone	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.
Pharmacodynamic parameter of YCT-529, including luteinizing hormone	Changes from pre-dose values of luteinizing hormone	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.
Pharmacodynamic parameter of YCT-529, including estradiol	Changes from pre-dose values of luteinizing hormone	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.
Pharmacodynamic parameter of YCT-529, including testosterone	Changes from pre-dose values of testosterone	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.
Changes in YCT-529 concentrations in semen	Changes in YCT-529 as measured by changes in serum concentrations in semen	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.

Collaborators and Investigators

• Sponsor: YourChoice Therapeutics, Inc.
• Investigators: Principal Investigator: Rohit Katia, MBChB, New Zealand Clinical Research

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: July 3, 2024
• First Submitted That Met QC Criteria: August 2, 2024
• First Posted (Actual): August 7, 2024

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: children; male; men; family planning; sperm motility; male contraception; orally administered; father; healthy males; vasectomy; non-hormonal; sperm count reduction; impaired spermatogenesis; impaired motility; awaiting vasectomy
• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Genetic Diseases, Inborn; Endocrine Gland Neoplasms; Neoplastic Syndromes, Hereditary; Neoplasms, Multiple Primary; Multiple Endocrine Neoplasia; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Multiple Endocrine Neoplasia Type 1
• Other Study ID Numbers: YCT-529-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No