Healthy Male VolunteersPhase 1NCT07868237
A Phase I Study to Investigate KH-001 in Healthy Males
A Phase 1 study testing KH-001 besylate in people with Healthy Male Volunteers, run by Kadence Bio at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Male Volunteers
- What is being tested?
- KH-001 besylate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Nov 2023to 28 Aug 2025
- Phase
- Phase 1
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 18 to 64 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male between 18 and 64 years of age, inclusive.
- For male participants with a female partner of childbearing potential, the contraception requirements for participation required the use of a condom by the male in addition to either one other highly effective method of contraception, or one other effective method of contraception by the female partner, if applicable, from first dose until 3 months after last dose.
- Body mass index (BMI) of 18-30 kg/m2.
- No clinically significant history of previous allergy / sensitivity to the investigational medicinal product (IMP) or any of the excipients contained within the IMP(s).
- No clinically significant abnormal test results for serum biochemistry, hematology and/or urine analyses within 28 days before the first dose administration of the IMP.
- Negative urinary drugs of abuse (DOA) screen (including alcohol) test results, determined within 28 days before the first dose administration of the IMP.
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- Negative human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) and hepatitis C virus antibody (HCV Ab) test results at Screening.
- No clinically significant abnormalities in 12-lead electrocardiogram (ECG) determined within 28 days before first dose of IMP including a PR interval > 220 ms, QT interval corrected using Fridericia's formula QTcF > 450 ms.
- No clinically significant abnormalities in vital signs (blood pressure/heart rate, respiratory rate, oral temperature) determined within 28 days before first dose of IMP.
- Available to complete the study (including all follow-up visits).
- Satisfied an Investigator about participant fitness to participate in the study.
- Provided written informed consent to participate in the study.
Who cannot join
- A clinically significant history of gastrointestinal disorder likely to influence IMP absorption.
- Allergic reaction to the IMP or history of reaction to relevant supplements.
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 28 days or 5 half-lives (whichever is longer) prior to the first dose of IMP.
- Evidence of any clinically significant history or the presence of renal, hepatic, respiratory, cardiovascular (hypertension, unstable angina, arrhythmia, QT prolongation, etc.), metabolic dysfunction, hematological, lymphatic or neurological diseases.
- Disorders of the central nervous system, psychiatric disorders, behavioral/behavior disturbances (e.g., cerebrovascular events, depression, post-traumatic stress disorder [PTSD], anxiety, bipolar disorder, severe migraine, Parkinson's disease).
- History of narrow angle glaucoma.
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- Have had a tattoo or piercing in the 3 months prior to Screening.
- Reported having experienced suicidal ideation (Type 4 or 5 on the Columbia-Suicide Severity Rating Scale [C-SSRS]) within 28 days prior to Screening, any suicidal behavior within 2 years prior to Screening (any "Yes" answers on the Suicidal Behavior section of C-SSRS), and/or the Investigator assessed the participant to be a safety risk to himself/herself or others.
- Past history of prostate cancer, benign prostatic hyperplasia (BPH) or other clinically significant prostate disease.
- Concomitant disease or condition that could have interfered with, or treatment which may have interfered with, the conduct of the study, or that would, in the opinion of the investigator, have posed an unacceptable risk to the participant in this study.
- Concomitant use of CNS medications (including anti-depressants, anti-psychotics), tramadol, topical anesthetics, phosphodiesterase 5 (PDE5) inhibitors or vasoactive penile injection therapy.
- A clinically significant current or history of drug or alcohol abuse (defined as the consumption of more than 14 units [for male participants] of alcohol a week) within the past two years.
- Inability to communicate well with the Investigators (i.e., language problem, poor mental development or impaired cerebral function).
- Participation in a New Chemical Entity (NCE) clinical study within the previous 3 months or five half-lives, whichever is longer, or a marketed drug clinical study within the 30 days or five half-lives, whichever is longer, before the first dose of IMP. (Washout period between studies is defined as the period of time elapsed between the last dose of the previous study and the first dose of the next study.)
- Donation of 450 mL or more blood within the 3 months before the first dose of IMP.
- Vegans, vegetarians or other dietary restrictions (e.g., restrictions for medical, religious or cultural reasons, etc.). Participants who preferred vegetarian options can be included if willing to follow available clinic meal options and all study procedures.
- Users of nicotine products i.e., current smokers or ex-smokers who have smoked within the 6 months prior to Screening or users of cigarette replacements (i.e., e-cigarettes, nicotine patches or gums).
- Participants who received a COVID-19 vaccine injection within 28 days prior to the first dose of IMP.
- Participants with pregnant or breastfeeding partners.
- Clinically significant maxillofacial pathology or tongue piercings in the 3 months prior to Screening (Formulation Effect only).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Simbec-Orion Clinical Pharmacology Unit
Merthyr Tydfil, South Wales, CF48 4DR
About this study
Official title: A Phase I, Randomised, Double-blind, Placebo-controlled First in Human Study to Assess the Safety and Pharmacokinetics of KH-001 Besylate in Healthy Male Participants
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.
Read the detailed description
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.
- Conditions
- Healthy Male Volunteers
- Being tested
- KH-001 besylate, KH-001 besylate placebo
- Keywords
- KH-001, KH-001 besylate, premature ejaculation, first-in-human, single ascending dose, multiple ascending dose, pharmacokinetics, safety, tolerability, orodispersible tablet
- Medical subject headings
- Premature Ejaculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KH-001 besylateDrug
Associated arm(s): 1 and 3
KH-001 besylate placeboDrug
Associated arm(s): Arm 2 (Placebo)
| Study group | Role | What they receive |
|---|---|---|
| KH-001 besylate (SAD and MAD) | Experimental | Single (7 doses) or multiple ascending (2 doses) doses of KH-001 besylate oral solution Receives: Drug: KH-001 besylate |
| Placebo (SAD and MAD) | Placebo comparator | Matching placebo administered by oral solution Receives: Drug: KH-001 besylate placebo |
| KH-001 besylate ODT (Formulation Effect) | Experimental | KH-001 besylate orodispersible tablet at two dose strengths, fixed-sequence crossover Receives: Drug: KH-001 besylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From screening through the final follow-up visit (up to Day 12)
Secondary outcomes (9)
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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: Formulation Effect treatment periods through follow-up (5-7 days after the final dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start14 Nov 2023
- Primary completion28 Aug 2025
- Study completion28 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male VolunteersStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- The study comprised three parts. SAD: 56 participants across 7 sequential dose-escalation cohorts of 8 (randomized 3:1 to KH-001 besylate or placebo), single dose. MAD: 18 participants across 2 sequential cohorts of 9 (randomized 2:1), once daily for 5 days. Formulation Effect: 8 participants in a non-randomized, open-label, fixed-sequence crossover comparing the oral solution with an ODT at two dose strengths.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kadence Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Annelize Koch, Dr, Principal investigator, Simbec-Orion Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07868237
- Sponsor's protocol ID
- KH-001-01-01
- Other IDs
- 2023-000058-83, 2023
- Status last verified
- Oct 2026
- First submitted
- 25 Sep 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.