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

• Sponsor: Chong Kun Dang Pharmaceutical (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05587699
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 5
• Anticipated Duration (Months): 10.5
• Patients Per Site Per Month: 3.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Alopecia	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	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized, Open-label, Multiple-dose and Parallel Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of CKD-843 A in Male Subjects
• Anticipated Study Start Date: Oct 26, 2022
• Anticipated Primary Completion Date: Sep 10, 2023
• Anticipated Study Completion Date: Sep 10, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. AUC0 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]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 50 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Severance Hospital	Seoul		Korea, Republic of	120-752

Sponsors and Collaborators

• Chong Kun Dang Pharmaceutical

Investigators

• Principal Investigator: Minsoo Park, M.D., Ph.D, Severance Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chong Kun Dang Pharmaceutical
• ClinicalTrials.gov Identifier: NCT05587699
• Other Study ID Numbers: A107_02PK2216
• First Posted: Oct 20, 2022
• Last Update Posted: Oct 20, 2022
• Last Verified: Oct 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Alopecia

Study Results

No Results Posted as of Oct 20, 2022