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RecruitingNCT06916793Updated Sep 3, 2026

A Phase 3 Study to Evaluate the Safety and Efficacy of CKD-843 in Male Patients With Androgenetic Alopecia

A Phase 3 interventional study of CKD-843 dose#1 and CKD-843 dose#2 in Androgenetic Alopecia, sponsored by Chong Kun Dang Pharmaceutical. Recruiting at 1 site in South Korea. Open to male participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-09-03.

Sponsored by Chong Kun Dang Pharmaceutical · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2025; still recruiting 1 year 7 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
288
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Male
01

Study summary

This is a multi-centers, randomized, double-blind, parallel-group, Phase 3 Trial to evaluate the efficacy and safety of CKD-843 in Male patients with Androgenetic Alopecia

Read the detailed description

The participants were randomly assigned to one of the following groups: CKD-843 dose #1, CKD-843 dose #2, placebo, or Dutasteride group. They received the assigned medication, placebo for blinding, or the reference drug over a 12-month period.

02

Conditions studied

  • Androgenetic Alopecia

Browse trials for

03

In context

Alopecia

511 studies on the registry are indexed under Alopecia; 128 are open to participants now.

This study's planned enrollment of 288 is above the median of 50 across 430 interventional studies indexed under Alopecia.

Browse Alopecia studies →

Lead sponsor

Chong Kun Dang Pharmaceutical is the lead sponsor of 299 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  • Male of age 18-50 years
  • Clinical Diagnosis of Androgenetic Alopecia
  • Written

Key Exclusion Criteria:

  • Other types of Alopecia or other diseases that can cause hair loss
  • scalp disease such as seborrheic dermatitis or psoriasis
  • Clinically significant hepatic disease, thyroid disease, or mental illness, as determined by the Investigator
  • Participants who do not agree to use during the trial and for 24 weeks after the last dose, and plan to provide sperm or conceive within 24 weeks after the last dose
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
288 participants (estimated)

Study arms

  • Experimental
    Test Group1

    CKD-843 dose#1 + Placebo of Dutasteride Capsule

    Drug: CKD-843 dose#1 · Drug: Placebo of Dutasteride Capsule

  • Experimental
    Test Group2

    CKD-843 dose#2 + Placebo of Dutasteride Capsule

    Drug: CKD-843 dose#2 · Drug: Placebo of Dutasteride Capsule

  • Placebo comparator
    Placebo-controlled Group

    Placebo of CKD-843 dose + Placebo of Dutasteride Capsule

    Drug: Placebo of CKD-843 dose · Drug: Placebo of Dutasteride Capsule

  • Active comparator
    Active-controlled Group

    Placebo of CKD-843 dose + Dutasteride Capsules

    Drug: Placebo of CKD-843 dose · Drug: Dutasteride Capsules

Interventions

  • IM injection every 3 months for 12 months

  • IM injection every 3 months for 12 months

  • DrugPlacebo of CKD-843 dose

    IM injection every 3 months for 12 months

  • oral, once daily, 12 months

  • DrugPlacebo of Dutasteride Capsule

    oral, once daily, 12 months

06

What researchers measure

Primary outcomes

  1. Total number of hair Changes

    from Baseline at Week24 of total number of hair changes

    Time frame: Baseline, Week 24

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06916793
Responsible party
Sponsor
First posted
Apr 8, 2025
Start date
Apr 8, 2025
Primary completion
Sep 30, 2027 (estimated)
Completion
Jun 30, 2028 (estimated)
Last update
Sep 3, 2026

Study contacts

OhSang Kwon, MD, PhD
Contact
oskwon@snu.ac.kr
+2-2072-2417
OhSang Kwon, MD, PhD
principal investigator · Seoul National University Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: CKD-843

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