New prostate drug enters early safety testing
NCT ID NCT07404735
First seen Jun 27, 2026 · Last updated Jul 22, 2026 · Updated 2 times
Summary
This early-stage trial tests a new drug called CKD-846 in 32 healthy men with benign prostate hypertrophy (enlarged prostate). The main goal is to see how the drug moves through the body and if it is safe. Participants must be men aged 19 to 55 with a healthy weight.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
34 people
The number who actually took part.
- Started
-
Feb 2026
- Finished
-
Jun 2026
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
19 to 55 years
- Sex
-
Male participants only
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Healthy man aged between 19 to 55 at screening 2. Weight ≥ 55kg 3. Body mass index (BMI) of 18.5 to 27.0kg/m2 4. Those who agree to contraception from the first Investigational Product(IP) dosing day till 6 months after the last dosing day and decide not to provide sperm during the participation of clinical trial 5. Those who voluntarily decide to participate in paper and agree to comply with the cautions after fully understand the detailed description of this clinical trial Exclusion Criteria: 1. Those who have clinically significant disease or medical history of Hepatopathy, Renal, Neurological, Immunity, Respiratory, Endocrine, urinary, tumor or Psychical disorder 2. Those who have a history of clinically significant cardiovascular diseases such as myocardial infarction, angina pectoris, ventricular arrhythmia, heart failure, left ventricular outflow tract stenosis, stroke, and transient ischemic attack within 2 years prior to the first administration of the investigational drug 3. Those with eye diseases including genetic degenerative retinal diseases, including retinitis pigmentosa 4. Those with a past history of erection lasting more than 4 hours and priapism while taking PDE5 inhibitors such as tadalafil 5. Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery which can interfere with drug absorption 6. Persons with a history of clinically significant hypersensitivity to drugs or additives, including ingredients of clinical investigational drugs 7. Those who have genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption 8. A person who is judged to be unsuitable as a test subject in a screening test conducted within 28 days before administration of the investigational drug 9. Those who has a drug abuse history within one year or positive reaction on urine drug screening test. 10. Those who has taken over-the-counter or prescription drugs, excluding topical agents without significant systemic absorption, within a specified period of time and the administered drug is judged to have an effect on this test or may affect the safety of the subject 11. People who need to take nitrate preparations or nitric oxide donors etc. regularly or intermittently during the clinical trial period 12. Those who continuously smoke excessively or consume caffeine or alcohol 13. A person who consumed food containing grapefruit within 7 days before the first administration of the investigational drug 14. Persons who participated in another clinical trial (including bioequivalence test) and received an investigational drug within 180days prior to the date of first administration of the investigational drug 15. Those who donated whole blood within 60 days before the first date of administration and donated ingredients within 30 days 16. Those who have received blood transfusion in 30 days 17. Those who are deemed insufficient to participate in clinical study by investigators
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Severance Hospital
Seoul, South Korea
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Other studies related to the condition(s) this trial covers.
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