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

NCT07404735 | Not Yet Recruiting Phase 1

• 1 other identifier: A133_02PK2504
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

A Clinical trial to compare and evaluate evaluate the pharmacokinetics and safety of CKD-846

Conditions

Benign Prostate Hypertrophy(BPH)

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (4)

A1 (Test group)

EXPERIMENTAL

CKD-846, Single dose

Drug: CKD-846

A2 (Test group)

EXPERIMENTAL

CKD-846, Single dose

Drug: CKD-846

A3 (Test group)

EXPERIMENTAL

CKD-846, Single dose

Drug: CKD-846

R (Reference group)

EXPERIMENTAL

D091, Multi dose

Drug: D091

Interventions

CKD-846 DRUG

once administration of Investigational Product

A1 (Test group); A2 (Test group); A3 (Test group)

D091 DRUG

once administration of Investigational Product

R (Reference group)

Eligibility Criteria

• Age: 19 Years - 55 Years
• Gender Eligibility Details: Male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

MinSoo Park

CONTACT

+82-02-2228-0401; MINSPARK@YUHS.AC

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 11, 2026
• Study Start: February 23, 2026
• Primary Completion (Estimated): May 27, 2026
• Study Completion (Estimated): June 2, 2026
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)