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

NCT05587699 | Completed Phase 1

• 1 other identifier: A107_02PK2216
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alopecia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (5)

Group - A1(Part 1)

EXPERIMENTAL

CKD-843 A 45mg

Drug: CKD-843 A 45mg(Multiple dose)

Group - A2(Part 2)

EXPERIMENTAL

CKD-843 A 45mg

Drug: CKD-843 A 45mg

Group - B1(Part 1)

EXPERIMENTAL

CKD-843 A 55mg

Drug: CKD-843 A 55mg(Multiple dose)

Group - B2(Part 2)

EXPERIMENTAL

CKD-843 A 55mg

Drug: CKD-843 A 55mg

Group - R(Part 1)

ACTIVE COMPARATOR

CKD-843-R

Drug: CKD-843-R

Interventions

CKD-843 A 45mg(Multiple dose) DRUG

1 Injection/3 Month, 3 times Injections

Group - A1(Part 1)

CKD-843 A 45mg DRUG

Single Injection

Group - A2(Part 2)

CKD-843 A 55mg(Multiple dose) DRUG

1 Injection/3 Month, 3 times Injections

Group - B1(Part 1)

CKD-843 A 55mg DRUG

Single Injection

Group - B2(Part 2)

CKD-843-R DRUG

0.5mg/day, 9 Month

Group - R(Part 1)

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Severance Hospital

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Minsoo Park, M.D., Ph.D

  Severance Hospital

  PRINCIPAL INVESTIGATOR

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: October 18, 2022
• First Posted: October 20, 2022
• Study Start: November 15, 2022
• Primary Completion: September 15, 2023
• Study Completion: October 17, 2023
• Last Updated: January 22, 2024

Record last verified: 2024-01

Locations

KR (1)