To Evaluate Efficacy, Safety, and Tolerability of KX-826 in Male Subjects With Androgenetic Alopecia

  • STATUS
    Recruiting
  • End date
    Jan 20, 2023
  • participants needed
    120
  • sponsor
    Suzhou Kintor Pharmaceutical Inc,
Updated on 13 April 2022
treatment regimen
covid-19
androgenic alopecia
Accepts healthy volunteers

Summary

The study is a randomized, double-blind, placebo-controlled, parallel group, phase 2 study to evaluate the efficacy, safety and tolerability of KX-826 in male subjects with androgenetic alopecia.

Description

KX-826 is a new investigational androgen receptor (AR) antagonist for the treatment of male pattern hair loss (androgenetic alopecia). A total of 120 subjects will be randomized to one of four cohorts: 2.5 mg BID, 5 mg QD, 5mg BID of KX-826 or placebo (BID or QD) for 24 weeks. The primary endpoint of the study is to assess the changes from baseline in non-vellus TAHC (Target Area Hair Counts)at Week 24 in comparison to placebo

Details
Condition Alopecia, Male Pattern Hair Loss
Treatment KX- 826 dosed at 2.5mg, KX-826 dosed at 5mg, Matching placebo to KX-826
Clinical Study IdentifierNCT05218642
SponsorSuzhou Kintor Pharmaceutical Inc,
Last Modified on13 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Subject is capable of giving informed consent and complying with study procedures
Subject is male between the ages of 18 and 70 years, inclusive
Subject has a clinical diagnosis of mild to moderate androgenetic alopecia; rating IIIv, IV and V on the Norwood Hamilton Scale, with a history of ongoing hair loss
Subject is willing to maintain the same hairstyle, hair length, and hair color throughout the study
Subject agrees to continue his other general hair care products and regimen for the entire study
Subject is considered healthy by the Principal Investigator, based on a detailed medical history, full physical examination, clinical laboratory tests, 12-lead ECG and vital signs (systolic blood pressure ≥90 and
≤150 mmHg, diastolic blood pressure ≥50 and ≤95 mmHg and pulse rate
≥45 and ≤100 bpm; one repeat of results is allowed to evaluate out of range
values)
Negative COVID-19 results within 3 days prior first dosing

Exclusion Criteria

Subject has any dermatological disorders of the scalp in the target region with the possibility of interfering with the application of the investigational drug, such as fungal or bacterial infections, seborrheic dermatitis, psoriasis, eczema, folliculitis, scars, or scalp atrophy
Subject has any skin pathology or condition that, in the investigator's opinion, could interfere with the evaluation of the investigational drug or requires use of interfering topical, systemic (e.g., uncontrolled thyroid disease, certain genetic disorders that involve hair growth or patterns), or surgical therapy
Subject has current or recent history (within 12 months) of hair weaves, non-breathable wigs, or hair bonding
Subject had scalp hair transplants at any time
Subject has a history or active hair loss due to diffuse telogen effluvium, alopecia areata, scarring alopecia, trichotillomania, or conditions/ diseases other than AGA
Subject has a current or recent history (within six months) of severe dietary or weight changes or has a history of eating disorder(s); if such has resulted in hair loss
Any disorder, including but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could
Affect the safety of the subject throughout the study
Influence the findings of the studies or their interpretations
Impede the subject's ability to complete the entire duration of study
Subject is currently enrolled in an investigational drug or device study
Subject has used an investigational drug or investigational device treatment within 30 days prior to randomization
Subject is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function
Subject may be unreliable for the study including subjects who engage in excessive alcohol intake or drug abuse (defined as any illicit drug use), or subjects who are unable to return for scheduled follow-up visits
Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody
Subject has a known hypersensitivity or previous allergic reaction to any of the active or inactive ingredients in the investigational drug or tattoo ink
Subject has used any of the following topical preparations or procedures on the scalp
Topical scalp treatments for hair growth including minoxidil, hormone therapy, anti-androgens, or other agents that are known to affect hair growth within 12 weeks of randomization
Use of hair regrowth products, including minoxidil, for >4 continuous weeks within 6 months before randomization
Medical shampoos or solutions which include Ketoconazole or the like (e.g. Terzolin) within four weeks prior to randomization
Topical scalp over-the-counter (OTC) or cosmetic treatments known or reasonably believed to affect hair growth (e.g., brands such as Aminexil, Maxilene, Nioxin, Foltene, etc.) or hair health or hair growth products with saw palmetto, copper, etc. within four weeks of randomization
Topical scalp treatments that may have ancillary effect on hair growth including, but not limited to, corticosteroids, pimecrolimus, tacrolimus, and retinoids within four weeks of randomization
Scalp procedures (surgical, laser, light, or energy treatments, microneedling, etc.) within six months of randomization
Platelet rich plasma (PRP) procedure on the scalp at any time point
Subject has used the following systemic medications or procedures
Beta blockers, cimetidine, diazoxide, or corticosteroids (including intramuscular and intralesional injections) within 12 weeks of randomization. Inhaled, intranasal, or ocular corticosteroids are allowed if use is stable [defined as doses and frequency unchanged for at least four weeks prior to randomization]
Retinoid, isotretinoin, vitamin A intake above 10,000 IU per day, or cyclosporine therapy within six months of randomization
Use of immunoglobulins/immunomodulators (eg, cyclosporin) for >4 continuous weeks within 6 months of randomization
Use of 5-α-reductase inhibitors (eg, finasteride or dutasteride) and/ or antiandrogens within 12 months before randomization
Use of systemic cimetidine or ketoconazole for >2 continuous weeks within 3 months before randomization
Chemotherapy or cytotoxic agents within 12 months of randomization
Radiation of the scalp at any time point
Use of systemic corticosteroids within 2 months of randomization for >2 consecutive weeks
Other systemic therapy, which in the opinion of the investigator, may materially affect the subject's hair or hair growth, including, but not limited to, vitamin or homeopathy supplement hair growth or hair health products or other steroid hormones (in any form), including anabolic steroids
An unwillingness of male participants to use highly effective contraceptive measures
if engaging in sexual intercourse with a female partner of childbearing
potential. Highly effective measures include use of a condom and spermicide
and, for female partners, use of an intrauterine device (IUD), diaphragm with
spermicide, oral contraceptives, injectable progesterone, progesterone
subdermal implants, or a tubal ligation
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