Trials Sponsors Conditions Drugs Pricing

Conditions

Keywords

malenon-hormonalmale contraceptionhealthy malessperm count reductionsperm motilityimpaired spermatogenesisimpaired motilityorally administeredvasectomyvasectomized men

Outcome Measures

Primary Outcomes (13)

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.
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)
Baseline to Day 15
Vital signs assessment (blood pressure)
Changes from pre-dose values (mm hg)
Baseline to Day 15

Study Arms (2)

YCT-529

ACTIVE COMPARATOR

Oral single ascending dose(s)

Drug: YCT-529

Placebo

PLACEBO COMPARATOR

Placebo for YCT-529 Capsule

Drug: YCT-529 Placebo

Interventions

YCT-529Drug

Single oral dose (planned doses of 10, 30, 90 and 200 mg; dose levels will not exceed 250 mg

YCT-529

YCT-529 PlaceboDrug

YCT-529 Placebo

Placebo

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age25 Years - 60 Years

Sexmale(Gender-based eligibility)

Gender Eligibility DetailsSex assigned at birth is required to be "male"

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

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.

Sponsors & Collaborators

YourChoice Therapeutics, Inc.
Industrylead

Study Sites (1)

Quotient Sciences

Nottingham, East Midlands, NG11 6JS, United Kingdom

Related Publications (1)

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.
PMID: 40696162DERIVED

Study Officials

Sharan Sidhu, MBChB
Quotient Sciences
PRINCIPAL INVESTIGATOR

Enrollment

16 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details: Double blind, placebo controlled
Purpose: OTHER
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 3, 2023

First Posted

October 23, 2023

You may not qualify if:

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.
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.
+9 more criteria

First in Human Study Evaluating Single Ascending Oral Doses of YCT-529 in Healthy Males

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (13)

Study Arms (2)

YCT-529

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

Study Officials

Enrollment

Study Design

Study Record Dates

Secondary Outcomes (13)

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (13)

Study Arms (2)

YCT-529

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

Study Officials

Enrollment

Study Design

Study Record Dates

Secondary Outcomes (13)

You may not qualify if:

Data Sharing

Source record

Locations