The Parallel Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of CKD-843 A

A Randomized, Open-label, Multiple-dose and Parallel Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of CKD-843 A in Male Subjects

A study to evaluate the pharmacokinetics, pharmacodynamics, and safety of CKD-843 A in male subjects.

Study Overview

• Status: Completed
• Conditions: Alopecia
• Intervention / Treatment: Drug: CKD-843 A 45mg(Multiple dose); Drug: CKD-843 A 45mg; Drug: CKD-843 A 55mg(Multiple dose); Drug: CKD-843 A 55mg; Drug: CKD-843-R

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 120-752
    • Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 46 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Those who aged between 19 to 50

• (Part 1) Those who are diagnosed to androgenic alopecia and meet criteria BASP grade

  • M2~M3 or C2~C3 grade with V1~V3 or F1~F3
  • M1 or C1 grade with V2~V3 or F2~F3

• (Part 1) Those who consent to the condition write below

  • Scalp tattoo & to cutting hair for hair evaluation
  • Maintaining hair style & color
• (Part 2) Those who are healthy male (Regardless of alopecia)
• Those who has body weight ≥ 55kg

• Those who has calculated body mass index(BMI) of 18.5 ≤ ~ < 27.0 kg/m2

  • Body Mass Index, kg/m2= Body weight(kg)/[Height(m)2]
• Those who consent to proper contraception and do not donate sperm until 6 months after the last administration of investigational product
• Those who understanding the detailed description of this clinical trial and voluntarily decide to participate

Exclusion Criteria:

• Those who have clinically significant disease or medical history of Hepatopathy, Renal dysfunction, Neurological disorder, Immunity disorder, Respiratory disorder, Genitourinary system disorder, Hemato-oncology disorder, Cardiovascular disorder or Psychical disorder

• (Part 1) Those who meets the conditions write below

  • alopecia areata, telogen alopecia
  • Those who has psoriasis or folliculitis or scar on hair evaluation area
  • Those who has experience of platelet-enriched plasma treatment to scarp within 24 weeks before the first administration of investigational product
  • Those who has experience of light or laser treatment to scarp within 12 weeks before the first administration of investigational product
  • Those who has experience of prophylaxis or medication of hair loss within 14 days before the first administration of investigational product
• Those who take dutasteride or finasteride within 6 month before the first administration of investigational product

• Those who has hypersensitivity to dutasteride or other 5-alpha reductase related inhibitors.

  • (Part 1) Those who has hypersensitivity to tatto ink.

• Those who have the screening(D-28~D-2) test results write below

  • AST, ALT > 1.5 times higher than upper normal level
  • Total bilirubin > 1.5 times higher than upper normal level
  • eGFR (estimated Glomerular Filtration Rate, which is calculated by MDRD) < 60 mL/min/1.73m2
  • "Positive" or "Reactive" test result of Hepatitis B & C, HIV, RPR
  • Under 5 min resting condition, systolic blood pressure >150 mmHg or <90 mmHg, diastolic blood pressure >100 mmHg or <50 mmHg
• Those who has a drug abuse history within one year or positive reaction on urine drug screening test.
• Those who receive following drugs, which may affect results of clinical trial and safety Ethical-the-counter (ETC) drugs and herbal medicines within 14 days before the first administration and Over-the-counter (OTC) drugs, health foods and vitamin preparations within 7 days before the first administration of the investigational product.
• Those who take barbiturate and related (causing induction or inhibition of metabolism) drug within 30 days before the first administration of investigational product.

• Those who exceeding smoke & alcohol consumption criteria.

  • Smoke: > 10 cigarettes/day
  • Caffeine: > 5 cups/day
  • Alcohol > 210 g/week
• Those who take grapefruit within 7 days before the first administration of investigational product.
• Those who receive investigational product by participating in other clinical trial within 180 days before the first administration of investigational product.
• Those who donate whole blood within 60 days or apheresis within 30 days before the first administration of investigational product.
• Those who receive transfusion within 30 days before the first administration of investigational product.
• Those who are deemed inappropriate to participate in clinical trial 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

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group - A1(Part 1); CKD-843 A 45mg	Drug: CKD-843 A 45mg(Multiple dose); 1 Injection/3 Month, 3 times Injections
Experimental: Group - A2(Part 2); CKD-843 A 45mg	Drug: CKD-843 A 45mg; Single Injection
Experimental: Group - B1(Part 1); CKD-843 A 55mg	Drug: CKD-843 A 55mg(Multiple dose); 1 Injection/3 Month, 3 times Injections
Experimental: Group - B2(Part 2); CKD-843 A 55mg	Drug: CKD-843 A 55mg; Single Injection
Active Comparator: Group - R(Part 1); CKD-843-R	Drug: CKD-843-R; 0.5mg/day, 9 Month

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC0 to Day 271	Area under the concentration-time curve from time Day 1(Pre-dose) to Day 271	Pre-dose(Day 1 - 0 hour), Day 1 - 4 hours, Day 2, Day 8, Day 15, Day 30, Day 46, Day 61, Day 91, Day 91 - 4 hours, Day 92, Day 98, Day 105, Day 121, Day 136, Day 151, Day 181, Day 181 4 hours, Day 182, Day 188, Day 195, Day 211, Day 226, Day 241, Day 271

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Principal Investigator: Minsoo Park, M.D., Ph.D, Severance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2022
• Primary Completion (Actual): September 15, 2023
• Study Completion (Actual): October 17, 2023

Study Registration Dates

• First Submitted: October 18, 2022
• First Submitted That Met QC Criteria: October 18, 2022
• First Posted (Actual): October 20, 2022

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 18, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia
• Other Study ID Numbers: A107_02PK2216

Drug and device information, study documents

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