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Completed

NCT Number: NCT05587699

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

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

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Key information

Age range

19 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Severance Hospital

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CKD-843 A 45mg(Multiple dose)

Drug

1 Injection/3 Month, 3 times Injections

CKD-843 A 45mg

Drug

Single Injection

CKD-843 A 55mg(Multiple dose)

Drug

1 Injection/3 Month, 3 times Injections

CKD-843 A 55mg

Drug

Single Injection

CKD-843-R

Drug

0.5mg/day, 9 Month

Primary outcomes

  1. AUC0 to Day 271

    Time frame: 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

    Area under the concentration-time curve from time Day 1(Pre-dose) to Day 271

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 20, 2022
Registry last updated
Jan 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.