Male ContraceptionPhase 1NCT06094283
First in Human Study Evaluating Single Ascending Oral Doses of YCT-529 in Healthy Males
A Phase 1 study testing YCT-529 in people with Male Contraception, run by YourChoice Therapeutics, Inc. at 1 site in United Kingdom.
Trial summary
A single ascending oral dose(s) study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of YCT-529 in healthy male subjects. Read more about this study
- Who is it for?
- Ages 25 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Male Contraception
- What is being tested?
- YCT-529
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Dec 2023to 18 Jun 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male subject in good health as confirmed by physical examination, medical history, and clinical laboratory tests of blood and urine at the time of Screening.
- Subject must provide written informed consent.
- Subject must be willing and able to communicate and participate in the whole study.
- Subject is 25 to 60 years of age (inclusive).
- Subject has been vasectomized for at least 6 months prior to enrolment
- Subject has body mass index (BMI) 18.0 to 32.0 kg/m2.
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- Subject has no history of hormonal therapy uses in the 90 days prior to the first screening visit.
- Subject agrees to use a condom during the study until the final return visit to ensure the safety of the study participants and their sexual partner(s)
- Subjects will refrain from donating blood or plasma during the study.
- Subjects will not use cannabis or any recreational drugs for at least 120 days before completing Screening and during the study.
- In the opinion of the investigator, subject 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.
Who cannot join
- Men participating in another clinical study involving an investigational drug within the last 90 days prior to the first dosing or less than 5 elimination half-lives prior to first dosing, whichever is longer.
- Clinically significant abnormal physical and/or laboratory findings at Screening
- Abnormal serum chemistry values at screening or admission, that indicate liver or kidney dysfunction or that may be considered clinically significant, such as bilirubin of >20 micro mol/L and ALT, AST, GGT and ALP above the upper limit of normal.
- Evidence of renal impairment at screening, as indicated by an estimated eGFR of <80 mL/min/1.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI; 2009) equation.
- Use of androgens within 90 days before first screening visit.
- Ongoing use of body building nutritional supplements.
Show all 25Show fewer
- Systolic blood pressure (BP) >140 mmHg (<45 years) or >160 mmHg (≥45 years) and diastolic BP >90 mmHg at screening or predose.
- Clinically significant abnormal electrocardiogram (ECG) or a duration of corrected QT interval in ECG (QTc) interval of >450 msec at screening or predose.
- Known history of androgen deficiency due to hypothalamic-pituitary or testicular disease or multiple endocrine deficiencies.
- Known history of significant cardiovascular, renal, hepatic (cholecystectomy is not permitted), or prostatic disease or significant psychiatric illness. Gilbert's syndrome is allowed (subject will be excluded if total bilirubin is ≥1.5 x ULN if known Gilbert's syndrome). If subject 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).
- 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. This will be re-assessed at admission to Period 2 and Period 3 if applicable.
- Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients.
- Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active.
- 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.
- Known or suspected alcoholism or drug abuse within the last 2 years that may affect metabolism/transformation of steroid hormones or study treatment compliance.
- Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening.
- Regular alcohol consumption in males >14 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).
- Current smokers and those who have smoked within the last 6 months. A confirmed breath carbon monoxide reading of greater than 10 ppm at screening or admission.
- Confirmed positive drugs of abuse test result.
- Subjects 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 per day in the 14 days before IMP administration). COVID-19 vaccines are accepted concomitant medications. 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 subject; and if the use of medication is not considered to interfere with the objectives of the study.
- Male subjects with pregnant or lactating partners.
- Subjects 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 per day in the 14 days before IMP administration). COVID-19 vaccines are accepted concomitant medications. 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 subject; and if the use of medication is not considered to interfere with the objectives of the study.
- Any site staff member with delegated study responsibilities or a family member of a site staff member with delegated study responsibilities.
- Any other medical condition that, in the opinion of the investigator, could alter the subject's well-being, the study conduct, or the interpretability of the results.
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Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Quotient Sciences
Nottingham, East Midlands, NG11 6JS
About this study
Official title: Double-blind, Placebo Controlled, First in Human Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Oral Doses of YCT-529
A single ascending oral dose(s) study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of YCT-529 in healthy male subjects.
Read the detailed description
This is a Phase 1a, double-blind, placebo controlled, first in human study to evaluate the safety, tolerability, PK, and PD of YCT-529 in 2 cohorts of 8 subjects. Cohorts 1 and 2 will be dosed in the fasted state in Periods 1 and 2. Each cohort will receive two doses of study drug separated by a washout period. One cohort will then return for a third dose of study drug under fed conditions in Period 3 to study the effect of food on YCT-529.
- Conditions
- Male Contraception
- Being tested
- YCT-529, YCT-529 Placebo
- Keywords
- male, non-hormonal, male contraception, healthy males, sperm count reduction, sperm motility, impaired spermatogenesis, impaired motility, orally administered, vasectomy, vasectomized men
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YCT-529Drug
Single oral dose (planned doses of 10, 30, 90 and 200 mg; dose levels will not exceed 250 mg
YCT-529 PlaceboDrug
YCT-529 Placebo
| Study group | Role | What they receive |
|---|---|---|
| YCT-529 | Active comparator | Oral single ascending dose(s) Receives: Drug: YCT-529 |
| Placebo | Placebo comparator | Placebo for YCT-529 Capsule Receives: Drug: YCT-529 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 43 days for subjects participating in Cohorts 1 and 2 participating in the 2 periods; Baseline to 10 weeks for Cohorts 1 and 2 that also complete the fed portion of the study; and Baseline to 16 weeks if waiting for other cohorts to finish
Vital signs assessment (heart rate)
Changes from pre-dose values (beats per minute)
Measured: Baseline to Day 15
Vital signs assessment (blood pressure)
Changes from pre-dose values (mm hg)
Measured: Baseline to Day 15
Vital signs assessment (oral temperature)
Changes from pre-dose values (temperature in celsius degrees)
Measured: Baseline to Day 15
12-lead ECG assessment (heart rate)
Changes from pre-dose values (beats per minute)
Measured: Baseline to Day 15
12-lead ECG assessment (QT interval)
Changes from pre-dose values for QT internal length (msec)
Measured: Baseline to Day 15
12-lead ECG assessment (QTcF Interval)
Changes from pre-dose values for QTcF interval length (msec)
Measured: Baseline to Day 15
12-lead ECG assessment (PR Interval)
Changes from pre-dose values for PR interval length (msec)
Measured: Baseline to Day 15
12-lead ECG assessment (QRS Duration)
Changes from pre-dose values for QRS duration (msec)
Measured: Baseline to Day 15
Clinical laboratory assessments (hematology blood sample tests)
Changes from pre-dose values (Tests: Hemoglobin, Hematocrit, packed cell volume, Red blood cell, erythrocyte count, mean corpuscular volume, mean corpuscular hemoglobin, Mean corpuscular hemoglobin concentration, Platelet count, White blood cell, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils
Measured: Baseline to Day 15
Clinical laboratory assessments (coagulation blood sample tests)
Changes from pre-dose values (Tests: Prothrombin time, Activated partial thromboplastin time (APTT), Fibrinogen)
Measured: Baseline to Day 15
Clinical laboratory assessments (clinical chemistry blood sample tests)
Changes from pre-dose values (Tests: Sodium, Potassium, Chloride, Bicarbonate, Urea, Creatinine, Bilirubin (total), Bilirubin (direct; only if total is elevated), Alkaline phosphatase, Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Lactate dehydrogenase (LDH), Creatine kinase (CK), Gamma glutamyl transferase (GGT), Protein (Total), Albumin, Calcium, Glucose (fasting), Glucose,Triglycerides (fasting) Cholesterol (total; fasting)
Measured: Baseline to Day 15
Clinical laboratory assessments (urine sample tests)
Changes from pre-dose values (Bilirubin, Urobilinogen, Ketones, Glucose, Protein, Blood, Nitrites, pH, Specific gravity, Leukocytes)
Measured: Baseline to Day 15
Secondary outcomes (13)
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],
Measured: Pre-dose to 336 hours after dosing
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]
Measured: Pre-dose to 336 hours after dosing
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]
Measured: Pre-dose to 336 hours after dosing
Plasma PK Parameter of YCT-529 (Time to maximum concentration [Tmax])
Plasma PK Parameter as measured by time to maximum concentration [Tmax]
Measured: Pre-dose to 336 hours after dosing
Plasma PK Parameter of YCT-529 (Terminal elimination half life [T1/2])
Plasma PK Parameter as measured by terminal elimination half life [T1/2]
Measured: Pre-dose to 336 hours after dosing
Plasma PK Parameter of YCT-529 (Lag time [Tlag])
Plasma PK Parameter as measured by lag time [Tlag]
Measured: Pre-dose to 336 hours after dosing
Plasma PK Parameter of YCT-529 (Volume of distribution [Vz/F])
Plasma PK Parameter as measured by apparent volume of distribution [Vz/F]
Measured: Pre-dose to 336 hours after dosing
Plasma PK Parameter of YCT-529 (oral clearance [CL/F])
Plasma PK Parameter as measured by oral clearance [CL/F] of YCT-529, including the effect of food on the PK
Measured: Pre-dose to 336 hours after dosing
Plasma PK Parameter of YCT-529 (maximum concentration [Cmax])
Plasma PK Parameter as measured by maximum concentration [Cmax]) of YCT-529, including the effect of food on the PK
Measured: Pre-dose to 336 hours after dosing
Pharmacodynamic parameter of YCT-529, including follicle-stimulating hormone
Changes from pre-dose values of follicle-stimulating hormone
Measured: Pre-dose to 336 hours after dosing
Pharmacodynamic parameter of YCT-529, including luteinizing hormone
Changes from pre-dose values of luteinizing hormone
Measured: Pre-dose to 336 hours after dosing
Pharmacodynamic parameter of YCT-529, including testosterone
Changes from pre-dose values of testosterone
Measured: Pre-dose to 336 hours after dosing
Pharmacodynamic parameter of YCT-529, including sex hormone binding globulin
Changes from pre-dose values of including sex hormone binding globulin
Measured: Pre-dose to 336 hours after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start20 Dec 2023
- Primary completion18 Jun 2024
- Study completion18 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Male ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In each cohort, the first 2 sentinel subjects will be randomized in a 1:1 ratio to receive either YCT-529 or placebo. The remaining 6 subjects in each cohort will be enrolled in the dosing cohort such that 5 subjects will be randomized to receive YCT-529 and 1 subject will be randomized to receive placebo; therefore, a total of 6 subjects will be randomized to receive YCT-529 and 2 subjects will be randomized to receive placebo at each dose level.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- YourChoice Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sharan Sidhu, MBChB, Principal investigator, Quotient Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06094283
- Sponsor's protocol ID
- YCT-529-01
- Other IDs
- 1007466
- Status last verified
- Sep 2024
- First submitted
- 3 May 2023
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mannowetz N, McCallum SW, Sidhu S, Mena KH, Ruby EP, Castro-Santamaria R, Dodds E, Henderson D, Whitaker G, Wright H, Beaudoin S, Bakshi A. Safety and pharmacokinetics of the non-hormonal male contraceptive YCT-529. Commun Med (Lond). 2025 Jul 22;5(1):279. doi: 10.1038/s43856-025-01004-4.
PubMed 40696162
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Placebo Controlled, First in Human Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Oral Doses of YCT-529
- ClinicalTrials.gov ID
- NCT06094283
- Acronym / sponsor ID
- YCT-529-01
- Conditions
- Male Contraception
- Keywords
- male, non-hormonal, male contraception, healthy males, sperm count reduction, sperm motility, impaired spermatogenesis, impaired motility
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- YourChoice Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- 18 Jun 2024 (actual)
- Study completion
- 18 Jun 2024 (actual)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A single ascending oral dose(s) study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of YCT-529 in healthy male subjects.
Detailed description
This is a Phase 1a, double-blind, placebo controlled, first in human study to evaluate the safety, tolerability, PK, and PD of YCT-529 in 2 cohorts of 8 subjects. Cohorts 1 and 2 will be dosed in the fasted state in Periods 1 and 2. Each cohort will receive two doses of study drug separated by a washout period. One cohort will then return for a third dose of study drug under fed conditions in Period 3 to study the effect of food on YCT-529.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- In each cohort, the first 2 sentinel subjects will be randomized in a 1:1 ratio to receive either YCT-529 or placebo. The remaining 6 subjects in each cohort will be enrolled in the dosing cohort such that 5 subjects will be randomized to receive YCT-529 and 1 subject will be randomized to receive placebo; therefore, a total of 6 subjects will be randomized to receive YCT-529 and 2 subjects will be randomized to receive placebo at each dose level.
| Arm | Type | Receives |
|---|---|---|
| YCT-529 | Active comparator | Drug: YCT-529Oral single ascending dose(s) |
| Placebo | Placebo comparator | Drug: YCT-529 PlaceboPlacebo for YCT-529 Capsule |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Male subject in good health as confirmed by physical examination, medical history, and clinical laboratory tests of blood and urine at the time of Screening.
- Subject must provide written informed consent.
- Subject must be willing and able to communicate and participate in the whole study.
- Subject is 25 to 60 years of age (inclusive).
- Subject has been vasectomized for at least 6 months prior to enrolment
Key exclusion criteria (25 listed)
- Men participating in another clinical study involving an investigational drug within the last 90 days prior to the first dosing or less than 5 elimination half-lives prior to first dosing, whichever is longer.
- Clinically significant abnormal physical and/or laboratory findings at Screening
- Abnormal serum chemistry values at screening or admission, that indicate liver or kidney dysfunction or that may be considered clinically significant, such as bilirubin of >20 micro mol/L and ALT, AST, GGT and ALP above the upper limit of normal.
- Evidence of renal impairment at screening, as indicated by an estimated eGFR of <80 mL/min/1.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI; 2009) equation.
- Use of androgens within 90 days before first screening visit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YCT-529Single oral dose (planned doses of 10, 30, 90 and 200 mg; dose levels will not exceed 250 mg | Drug | YCT-529 |
| YCT-529 PlaceboYCT-529 Placebo | Drug | Placebo |
Primary outcome
The incidence and nature of any adverse events, dose-limiting adverse events and serious adverse adverse events.
Time frame: Baseline to 43 days for subjects participating in Cohorts 1 and 2 participating in the 2 periods; Baseline to 10 weeks for Cohorts 1 and 2 that also complete the fed portion of the study; and Baseline to 16 weeks if waiting for other cohorts to finish
Assessment of the number and type of adverse events, dose-limiting adverse events and serious adverse events following dosing.
Vital signs assessment (heart rate)
Time frame: Baseline to Day 15
Changes from pre-dose values (beats per minute)
Vital signs assessment (blood pressure)
Time frame: Baseline to Day 15
Changes from pre-dose values (mm hg)
Vital signs assessment (oral temperature)
Time frame: Baseline to Day 15
Changes from pre-dose values (temperature in celsius degrees)
12-lead ECG assessment (heart rate)
Time frame: Baseline to Day 15
Changes from pre-dose values (beats per minute)
12-lead ECG assessment (QT interval)
Time frame: Baseline to Day 15
Changes from pre-dose values for QT internal length (msec)
12-lead ECG assessment (QTcF Interval)
Time frame: Baseline to Day 15
Changes from pre-dose values for QTcF interval length (msec)
12-lead ECG assessment (PR Interval)
Time frame: Baseline to Day 15
Changes from pre-dose values for PR interval length (msec)
12-lead ECG assessment (QRS Duration)
Time frame: Baseline to Day 15
Changes from pre-dose values for QRS duration (msec)
Clinical laboratory assessments (hematology blood sample tests)
Time frame: Baseline to Day 15
Changes from pre-dose values (Tests: Hemoglobin, Hematocrit, packed cell volume, Red blood cell, erythrocyte count, mean corpuscular volume, mean corpuscular hemoglobin, Mean corpuscular hemoglobin concentration, Platelet count, White blood cell, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils
Clinical laboratory assessments (coagulation blood sample tests)
Time frame: Baseline to Day 15
Changes from pre-dose values (Tests: Prothrombin time, Activated partial thromboplastin time (APTT), Fibrinogen)
Clinical laboratory assessments (clinical chemistry blood sample tests)
Time frame: Baseline to Day 15
Changes from pre-dose values (Tests: Sodium, Potassium, Chloride, Bicarbonate, Urea, Creatinine, Bilirubin (total), Bilirubin (direct; only if total is elevated), Alkaline phosphatase, Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Lactate dehydrogenase (LDH), Creatine kinase (CK), Gamma glutamyl transferase (GGT), Protein (Total), Albumin, Calcium, Glucose (fasting), Glucose,Triglycerides (fasting) Cholesterol (total; fasting)
Clinical laboratory assessments (urine sample tests)
Time frame: Baseline to Day 15
Changes from pre-dose values (Bilirubin, Urobilinogen, Ketones, Glucose, Protein, Blood, Nitrites, pH, Specific gravity, Leukocytes)
13 secondary outcomes
Plasma PK Parameter of YCT-529 (Area under the curve to Infinity [AUCinf])
Time frame: Pre-dose to 336 hours after dosing
Plasma PK Parameter of YCT-529 (Area under the curve to the last measured concentration [AUC0-t])
Time frame: Pre-dose to 336 hours after dosing
Plasma PK Parameter of YCT-529 (Area under the curve to 24 hours [AUC0--24])
Time frame: Pre-dose to 336 hours after dosing
Plasma PK Parameter of YCT-529 (Time to maximum concentration [Tmax])
Time frame: Pre-dose to 336 hours after dosing
Plasma PK Parameter of YCT-529 (Terminal elimination half life [T1/2])
Time frame: Pre-dose to 336 hours after dosing
Plasma PK Parameter of YCT-529 (Lag time [Tlag])
Time frame: Pre-dose to 336 hours after dosing
Plasma PK Parameter of YCT-529 (Volume of distribution [Vz/F])
Time frame: Pre-dose to 336 hours after dosing
Plasma PK Parameter of YCT-529 (oral clearance [CL/F])
Time frame: Pre-dose to 336 hours after dosing
Plasma PK Parameter of YCT-529 (maximum concentration [Cmax])
Time frame: Pre-dose to 336 hours after dosing
Pharmacodynamic parameter of YCT-529, including follicle-stimulating hormone
Time frame: Pre-dose to 336 hours after dosing
Pharmacodynamic parameter of YCT-529, including luteinizing hormone
Time frame: Pre-dose to 336 hours after dosing
Pharmacodynamic parameter of YCT-529, including testosterone
Time frame: Pre-dose to 336 hours after dosing
Pharmacodynamic parameter of YCT-529, including sex hormone binding globulin
Time frame: Pre-dose to 336 hours after dosing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Derived from this study: PubMed 40696162Mannowetz N, McCallum SW, Sidhu S, Mena KH, Ruby EP, Castro-Santamaria R, Dodds E, Henderson D, Whitaker G, Wright H, Beaudoin S, Bakshi A. Safety and pharmacokinetics of the non-hormonal male contraceptive YCT-529. Commun Med (Lond). 2025 Jul 22;5(1):279. doi: 10.1038/s43856-025-01004-4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharan Sidhu, MBChB principal investigator
Quotient Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing YCT-529 in people with Male Contraception, run by YourChoice Therapeutics, Inc. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence and nature of any adverse events, dose-limiting adverse events and serious adverse adverse events. (time frame: Baseline to 43 days for subjects participating in Cohorts 1 and 2 participating in the 2 periods; Baseline to 10 weeks for Cohorts 1 and 2 that also complete the fed portion of the study; and Baseline to 16 weeks if waiting for other cohorts to finish). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06094283, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024.