A Phase 1 interventional study of KH-001 besylate and KH-001 besylate placebo in Healthy Male Volunteers, sponsored by Kadence Bio. Completed at 1 site in United Kingdom. Open to male participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Kadence Bio · Phase 1, Interventional, and Treatment
This was a Phase I, first-in-human study of KH-001 besylate in healthy male participants, conducted to investigate the safety, tolerability and pharmacokinetics (PK) of the study drug. The study was conducted in three parts: a single ascending dose (SAD) part, a multiple ascending dose (MAD) part, and a Formulation Effect part evaluating an orodispersible tablet (ODT) formulation. The study also evaluated the effect of KH-001 besylate on suicidality risk and mood. KH-001 besylate is being developed as an on-demand oral treatment for premature ejaculation.
This was a Phase I, first-in-human, randomized, double-blind, placebo-controlled study to assess the safety, tolerability and pharmacokinetics (PK) of KH-001 besylate following single ascending (SAD) and multiple ascending (MAD) doses in healthy male participants. The study also included a Formulation Effect part: a non-randomized, open-label, fixed-sequence crossover evaluation of safety, tolerability, PK, taste, dissolution time and formulation effect after an ODT dose in each period, comparing against the oral solution.
The SAD was conducted in 56 participants (4 cohorts of 8, with 3 additional cohorts of 8); each cohort of 8 was randomized 3:1 to KH-001 besylate or placebo, receiving a single dose in the fasted state. Participants underwent a screening period (Day -28 to Day -2), an in-house treatment period of 2 overnight stays (Day -1 to Day 2) and a follow-up visit on Day 6-8.
The MAD was conducted in 18 participants (2 cohorts of 9), each randomized 2:1 to KH-001 besylate or placebo, dosed once daily for 5 consecutive days. Participants underwent a screening period, an in-house period of 6 overnight stays (Day -1 to Day 6) and a follow-up visit on Day 10-12.
The Formulation Effect was conducted in 8 participants across two dose periods (open-label, fixed-sequence crossover), each period comprising 2 overnight stays and separated by a 7-day washout, with a follow-up 5-7 days after the final dose.
106 studies on the registry are indexed under Premature Ejaculation; 17 are open to participants now.
This study's enrollment of 82 is close to the median of 84 across 89 interventional studies indexed under Premature Ejaculation.
Browse Premature Ejaculation studies →Kadence Bio is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single (7 doses) or multiple ascending (2 doses) doses of KH-001 besylate oral solution
Drug: KH-001 besylate
Matching placebo administered by oral solution
Drug: KH-001 besylate placebo
KH-001 besylate orodispersible tablet at two dose strengths, fixed-sequence crossover
Drug: KH-001 besylate
Associated arm(s): 1 and 3
Associated arm(s): Arm 2 (Placebo)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Number of participants with one or more treatment-emergent adverse events (TEAEs), including serious adverse events, summarized by severity and relationship to study drug. Adverse events were assessed by the investigator throughout the study.
Time frame: From first dose of study drug through the final follow-up visit (up to Day 12)
Number of Participants With Clinically Significant Abnormal Clinical Laboratory Values
Number of participants with clinically significant abnormal clinical laboratory results (clinical chemistry/biochemistry, hematology, coagulation and urinalysis), as determined by the investigator.
Time frame: From screening through the final follow-up visit (up to Day 12)
Number of Participants With Clinically Significant Abnormal Vital Signs
Number of participants with clinically significant abnormal vital sign findings (systolic and diastolic blood pressure, heart rate, respiratory rate and oral body temperature), as determined by the investigator.
Time frame: From screening through the final follow-up visit (up to Day 12)
Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings
Number of participants with clinically significant abnormal 12-lead electrocardiogram (ECG) findings (including heart rate and the RR, PR, QRS, QT and QTcF intervals), as determined by the investigator.
Time frame: From screening through the final follow-up visit (up to Day 12)
Maximum Plasma Concentration (Cmax) of KH-001
Maximum observed plasma concentration (Cmax) of KH-001 following single ascending doses, multiple ascending doses, and the Formulation Effect (orodispersible tablet versus oral solution) part.
Time frame: Pre-dose to 24 hours post-dose (single dose; multiple-dose Days 1 and 5; each Formulation Effect period)
Number of Participants With Suicidal Ideation or Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Number of participants with suicidal ideation or suicidal behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS).
Time frame: From screening through the final follow-up visit (up to Day 12)
In-Mouth Dissolution Time of the KH-001 Besylate Orodispersible Tablet (ODT)
Time to complete in-mouth dissolution of the KH-001 besylate orodispersible tablet (ODT).
Time frame: Formulation Effect dosing (Day 1 of each treatment period)
Time to Maximum Plasma Concentration (Tmax) of KH-001
Time to maximum observed plasma concentration (Tmax) of KH-001 following single ascending doses, multiple ascending doses, and the Formulation Effect (orodispersible tablet versus oral solution) part.
Time frame: Pre-dose to 24 hours post-dose (single dose; multiple-dose Days 1 and 5; each Formulation Effect period)
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t) of KH-001
Area under the plasma concentration-time curve from time zero to the last quantifiable concentration (AUC0-t) of KH-001 following single ascending doses and the Formulation Effect (orodispersible tablet versus oral solution) part.
Time frame: Pre-dose to 24 hours post-dose (single dose; each Formulation Effect period)
Area Under the Plasma Concentration-Time Curve Over the Dosing Interval (AUC0-tau) of KH-001 at Steady State
Area under the plasma concentration-time curve over the dosing interval (AUC0-tau) of KH-001 at steady state following multiple ascending doses.
Time frame: Multiple-dose Day 5: pre-dose to 24 hours post-dose
Change From Baseline in Profile of Mood States (POMS) Total Mood Disturbance Score
Change from baseline in the Profile of Mood States (POMS) Total Mood Disturbance score, a self-reported measure of mood. Higher scores indicate greater mood disturbance (a worse outcome).
Time frame: Baseline and end of study (up to Day 12)
Taste Assessment Score of the KH-001 Besylate Orodispersible Tablet (ODT)
Participant-reported taste assessment of the KH-001 besylate orodispersible tablet (ODT), recorded on a taste assessment scale.
Time frame: Formulation Effect dosing (Day 1 of each treatment period)
Number of Participants With Oral-Cavity Findings on Local Tolerability Assessment After ODT Administration
Number of participants with abnormal oral-cavity findings on local tolerability assessment (oral-cavity examination, Oral Cavity Index and irritation scoring) following administration of the KH-001 besylate orodispersible tablet (ODT).
Time frame: Formulation Effect treatment periods through follow-up (5-7 days after the final dose)
Plan to share: No — The datasets generated and/or analyzed are not expected to be made available owing to the high commercial sensitivity of this Phase I study and the negligible public benefit of publishing results of non-therapeutic clinical trials.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: KH001