A Clinical Trial to Compare and Evaluate Evaluate the Pharmacokinetics and Safety of CKD-846

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

Study Overview

• Status: Not yet recruiting
• Conditions: Benign Prostate Hypertrophy(BPH)
• Intervention / Treatment: Drug: CKD-846; Drug: D091

Detailed Description

A randomized, open-label and parallel study to evaluate the pharmacokinetics and safety of CKD-846 in healthy male subjects

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: MinSoo Park; Phone Number: +82-02-2228-0401; Email: MINSPARK@YUHS.AC

Study Locations

• South Korea
  • Seoul, South Korea
    • Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: R (Reference group); D091, Multi dose	Drug: D091; once administration of Investigational Product
Experimental: A1 (Test group); CKD-846, Single dose	Drug: CKD-846; once administration of Investigational Product
Experimental: A2 (Test group); CKD-846, Single dose	Drug: CKD-846; once administration of Investigational Product
Experimental: A3 (Test group); CKD-846, Single dose	Drug: CKD-846; once administration of Investigational Product

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma Concentration of D091	Concentration of During the administration period	Pre-dose, Post-dose Day1~Day34 (During the administration period)
Plasma Concentration of CKD-846	Concentration of During the administration period	Pre-dose, Post-dose Day1~Day91 (During the administration period)

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical

Study record dates

Study Major Dates

• Study Start (Estimated): February 23, 2026
• Primary Completion (Estimated): May 27, 2026
• Study Completion (Estimated): June 2, 2026

Study Registration Dates

• First Submitted: January 29, 2026
• First Submitted That Met QC Criteria: February 8, 2026
• First Posted (Actual): February 11, 2026

Study Record Updates

• Last Update Posted (Actual): February 11, 2026
• Last Update Submitted That Met QC Criteria: February 8, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Hyperplasia
• Other Study ID Numbers: A133_02PK2504

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No