the Safety, Tolerability and PK of KX-826 in Healthy Males With Alopecia Following Topical Multiple Dose Ascending

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Brief Title

the Safety, Tolerability and PK of KX-826 in Healthy Males With Alopecia Following Topical Multiple Dose Ascending

Official Title

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose Escalation Study in Healthy Male Subjects With Androgenetic Alopecia to Evaluate the Safety, Tolerability and PK of KX-826 Following Topical Multiple Dose Ascending

Brief Summary

      The study is a randomized, double-blind, placebo-controlled, dose-escalation study to
      evaluate the safety, tolerability and PK of KX-826 following topical multiple ascending dose
      administration.
    

Detailed Description

      KX-826 topical solution will be applied to the scalp of healthy male subjects with
      androgenetic alopecia.

      A total of 40 subjects will be evaluated with 32 subjects randomized to receive active drug
      and 8 subjects randomized to receive placebo in a double-blind fashion (10 subjects in each
      dose cohort with 8 subjects randomized to receive active drug and 2 subjects randomized to
      receive placebo for a total of 4 dose cohorts).

      Cohort Dose of KX-826 Subjects

        1. 2.5 mg QD for 14 days 10 (8 active + 2 placebo)

        2. 5 mg QD for 14 days 10 (8 active + 2 placebo)

        3. 10 mg QD for 14 days 10 (8 active + 2 placebo)

        4. 20 mg QD for 14 days 10 (8 active + 2 placebo)

      Dose escalation will not occur until review of the multiple dose safety from the previous
      dose cohort is completed. Safety assessments will include monitoring of AEs, vital signs
      (blood pressure, pulse rate, respiratory rate and oral temperature), clinical laboratory
      findings, 12-lead ECGs, skin irritation assessments and physical examination findings.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Incidence of treatment-emergent adverse events (TEAE) by skin irritation assessment, vital sign, ECG and clinical lab assessments

Secondary Outcome

 Maximum observed concentration (Cmax)

Condition

Androgenetic Alopecia

Intervention

KX0826

Study Arms / Comparison Groups

 Experimental Group -KX0826
Description:  KX0826 is tropically applied to the scalp of healthy male subjects once a day for 14 days. The applied dosage cohorts are 2.5mg, 5mg, 10mg and 20mg.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

40

Start Date

January 14, 2020

Completion Date

November 30, 2020

Primary Completion Date

September 30, 2020

Eligibility Criteria

        Inclusion Criteria:

          1. Are capable of giving informed consent and complying with study procedures;

          2. Are males between the ages of 18 and 60 years, inclusive;

          3. Have a clinical diagnosis of androgenetic alopecia;

          4. 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 allowed to confirm out of range values);

          5. Have normal renal and hepatic function as determined by the screening laboratory
             results;

          6. Nonsmoker, defined as not having smoked or used any form of tobacco in more than 6
             months before screening;

          7. Body mass index (BMI) of 19.0 to 35.0 kg/m2 inclusive and body weight not less than 50
             kg;

          8. Willing and able to adhere to study restrictions and to be confined at the CRU

        Exclusion Criteria:

          1. Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal,
             endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic,
             immunologic, lipid metabolism disorders, or drug hypersensitivity;

          2. Any visible skin disease, damage or condition at the application site which, in the
             opinion of the investigator, could compromise subject safety and/or interfere with the
             evaluation of the test site reaction;

          3. Subject has any dermatological disorders of the scalp;

          4. Subject has a history of hair transplants, hair weaves;

          5. Subject has hypersensitivity to previously prescribed minoxidil or finasteride;

          6. Known or suspected malignancy;

          7. Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface
             antigen (HBsAg), or hepatitis C virus (HCV) antibody;

          8. A hospital admission or major surgery within 30 days prior to screening;

          9. Participation in any other investigational drug trial within 30 days prior to
             screening;

         10. A history of prescription drug abuse, or illicit drug use within 6 months prior to
             screening;

         11. A history of alcohol abuse according to medical history within 6 months prior to
             screening;

         12. A positive screen for alcohol or drugs of abuse;

         13. Donation or blood collection of more than 1 unit (approximate 450 mL) of blood (or
             blood products) or acute loss of blood during the 90 days prior to screening;

         14. Use of prescription or over-the-counter (OTC) medications, and herbal (including St
             John's Wort, herbal teas, garlic extracts) within 14 days prior to dosing (Note: Use
             of acetaminophen at <3g/day is permitted until 24 hours prior to dosing);

         15. An unwillingness of male participants to use appropriate contraceptive measures if
             engaging in sexual intercourse with a female partner of childbearing potential.
             Appropriate 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.
      

Gender

Male

Ages

18 Years - 60 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Phoebe Zhang, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04502901

Organization ID

KX0826-US-1002


Responsible Party

Sponsor

Study Sponsor

Suzhou Kintor Pharmaceutical Inc,


Study Sponsor

Phoebe Zhang, Study Director, Suzhou Kintor Pharmaceuticals Inc.


Verification Date

July 2020