Benign Prostate Hypertrophy(BPH)Phase 1NCT07404735
A Clinical Trial to Compare and Evaluate Evaluate the Pharmacokinetics and Safety of CKD-846
A Phase 1 study testing CKD-846 and D091 in people with Benign Prostate Hypertrophy(BPH), run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
A Clinical trial to compare and evaluate evaluate the pharmacokinetics and safety of CKD-846 Read more about this study
- Who is it for?
- Ages 19 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Benign Prostate Hypertrophy(BPH)
- What is being tested?
- CKD-846 and D091
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Feb 2026to 12 Jun 2026
- 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 19 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy man aged between 19 to 55 at screening
- Weight ≥ 55kg
- Body mass index (BMI) of 18.5 to 27.0kg/m2
- 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
- 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
Who cannot join
- Those who have clinically significant disease or medical history of Hepatopathy, Renal, Neurological, Immunity, Respiratory, Endocrine, urinary, tumor or Psychical disorder
- 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
- Those with eye diseases including genetic degenerative retinal diseases, including retinitis pigmentosa
- Those with a past history of erection lasting more than 4 hours and priapism while taking PDE5 inhibitors such as tadalafil
- Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery which can interfere with drug absorption
- Persons with a history of clinically significant hypersensitivity to drugs or additives, including ingredients of clinical investigational drugs
Show all 17Show fewer
- Those who have genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- 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
- Those who has a drug abuse history within one year or positive reaction on urine drug screening test.
- 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
- People who need to take nitrate preparations or nitric oxide donors etc. regularly or intermittently during the clinical trial period
- Those who continuously smoke excessively or consume caffeine or alcohol
- A person who consumed food containing grapefruit within 7 days before the first administration of the investigational drug
- 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
- Those who donated whole blood within 60 days before the first date of administration and donated ingredients within 30 days
- Those who have received blood transfusion in 30 days
- Those who are deemed insufficient to participate in clinical study by investigators
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label and Parallel Study to Evaluate the Pharmacokinetics and Safety of CKD-846 in Healthy Male Subjects
A Clinical trial to compare and evaluate evaluate the pharmacokinetics and safety of CKD-846
Read the detailed description
A randomized, open-label and parallel study to evaluate the pharmacokinetics and safety of CKD-846 in healthy male subjects
- Conditions
- Benign Prostate Hypertrophy(BPH)
- Being tested
- CKD-846, D091
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CKD-846Drug
once administration of Investigational Product
D091Drug
once administration of Investigational Product
| Study group | Role | What they receive |
|---|---|---|
| A1 (Test group) | Experimental | CKD-846, Single dose Receives: Drug: CKD-846 |
| A2 (Test group) | Experimental | CKD-846, Single dose Receives: Drug: CKD-846 |
| A3 (Test group) | Experimental | CKD-846, Single dose Receives: Drug: CKD-846 |
| R (Reference group) | Experimental | D091, Multi dose Receives: Drug: D091 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Concentration of D091
Concentration of During the administration period
Measured: Pre-dose, Post-dose Day1~Day34 (During the administration period)
Plasma Concentration of CKD-846
Concentration of During the administration period
Measured: Pre-dose, Post-dose Day1~Day91 (During the administration period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start23 Feb 2026
- Primary completion2 Jun 2026
- Study completion12 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostate Hypertrophy(BPH)Studies of the same condition, open and under way.
- More trials run by Chong Kun Dang PharmaceuticalThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07404735
- Sponsor's protocol ID
- A133_02PK2504
- Status last verified
- Jul 2026
- First submitted
- 29 Jan 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label and Parallel Study to Evaluate the Pharmacokinetics and Safety of CKD-846 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT07404735
- Acronym / sponsor ID
- A133_02PK2504
- Conditions
- Benign Prostate Hypertrophy(BPH)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 23 Feb 2026 (actual)
- Primary completion
- 2 Jun 2026 (actual)
- Study completion
- 12 Jun 2026 (actual)
- First posted
- 11 Feb 2026 (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 Clinical trial to compare and evaluate evaluate the pharmacokinetics and safety of CKD-846
Detailed description
A randomized, open-label and parallel study to evaluate the pharmacokinetics and safety of CKD-846 in healthy male subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A1 (Test group) | Experimental | Drug: CKD-846CKD-846, Single dose |
| A2 (Test group) | Experimental | Drug: CKD-846CKD-846, Single dose |
| A3 (Test group) | Experimental | Drug: CKD-846CKD-846, Single dose |
| R (Reference group) | Experimental | Drug: D091D091, Multi dose |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy man aged between 19 to 55 at screening
- Weight ≥ 55kg
- Body mass index (BMI) of 18.5 to 27.0kg/m2
- 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
- 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
Key exclusion criteria (17 listed)
- Those who have clinically significant disease or medical history of Hepatopathy, Renal, Neurological, Immunity, Respiratory, Endocrine, urinary, tumor or Psychical disorder
- 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
- Those with eye diseases including genetic degenerative retinal diseases, including retinitis pigmentosa
- Those with a past history of erection lasting more than 4 hours and priapism while taking PDE5 inhibitors such as tadalafil
- Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery which can interfere with drug absorption
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 |
|---|---|---|
| CKD-846once administration of Investigational Product | Drug | A1 (Test group), A2 (Test group), A3 (Test group) |
| D091once administration of Investigational Product | Drug | R (Reference group) |
Primary outcome
Plasma Concentration of D091
Time frame: Pre-dose, Post-dose Day1~Day34 (During the administration period)
Concentration of During the administration period
Plasma Concentration of CKD-846
Time frame: Pre-dose, Post-dose Day1~Day91 (During the administration period)
Concentration of During the administration period
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 21 Jul 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 CKD-846 and D091 in people with Benign Prostate Hypertrophy(BPH), run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
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 5 inclusion and 17 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 21 Jul 2026. 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 South Korea. 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. 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?
Plasma Concentration of D091 (time frame: Pre-dose, Post-dose Day1~Day34 (During the administration period)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jul 2026.