| Eligibility |
Inclusion Criteria:
To enter the study, a subject must meet the following criteria:
1. Subject is male, 18-55 years old.
2. Subject has provided written informed consent.
3. Subject has a clinical diagnosis of moderate to severe AGA in temple and vertex
region, III to VI on the Modified Norwood-Hamilton Scale (i.e., III, IV, V, and VI).
4. Subject is willing and able to apply the test article(s) as directed, comply with
study instructions, and commit to all follow-up visits for the duration of the study.
5. Subject, in the investigator's opinion, is in good general health and free of any
disease state or physical condition that might impair evaluation of AGA or exposes the
subject to an unacceptable risk by study participation.
6. Subject has normal renal, thyroid, and hepatic function as determined by the Visit
1/Screening laboratory results in the opinion of the investigator.
7. Subject is a non-smoker, defined as not having smoked or used any form of tobacco or
non-tobacco products containing nicotine in more than 6 months before Visit
2/Baseline.
8. Subject has a body mass index (BMI) of 19 to 32 kg/m2 inclusive and body weight not
less than 50 kg at Visit 1/Screening.
9. Subject agrees to continue his other general hair care products and regimen for at
least 2 weeks prior to Visit 2/Baseline, and through the entire study.
10. Subjects who are sexually active with a female partner and are not surgically sterile
(vasectomy performed at least 6 months prior to treatment) must agree to refrain from
sperm donation for at least 90 days after administration of their last dose of test
article(s) and inform their non-pregant female sexual partner to use a highly
effective form of birth control as described in the informed consent form. Note:
Female partner must be confirmed according to subject to be non-pregnant at Visit
1/Screening and Visit 2/Baseline or at the visit when a subject identifies a new
sexual partner.
Exclusion Criteria:
A subject is ineligible to enter the study if he meets 1 or more of the following criteria:
1. Subject has any dermatological disorders of the scalp on the regions that are bald and
thinning with the possibility of interfering with the application of the test article
or examination method, such as fungal or bacterial infections, seborrheic dermatitis,
psoriasis, eczema, folliculitis, scars, or scalp atrophy.
2. Subject has any skin pathology or condition (e.g., uncontrolled thyroid disease,
certain genetic disorders that involve hair growth or patterns) that, in the
investigator's opinion, could interfere with the evaluation of the test article or
requires use of interfering topical, systemic, or surgical therapy.
3. Subject has any visible inflammatory skin disease, injury, or condition of their scalp
that could compromise subject safety and/or interfere with the evaluation of local or
systemic assessments performed during the study.
4. Subject has a history of scalp reduction or notable trauma with related scarring, hair
transplants, and/or hair weaves.
5. Subject has a known or suspected malignancy.
6. Subject has a positive blood screen for human immunodeficiency virus (HIV), hepatitis
B surface antigen (HBsAg), or hepatitis C antibody.
7. Subject has any condition, which, in the investigator's opinion, would make it unsafe
for the subject to participate in this study, including clinically significant
abnormal laboratory or 12-lead electrocardiogram (ECG) findings during the screening
period or Visit 2/Baseline prior to dosing of the test article.
8. Subject has a hospital admission or major surgery within 30 days prior to Visit 2/
Baseline or planned for during the study.
9. Subject is currently enrolled in an investigational drug, biologic, or device study.
10. Subject has used an investigational drug, investigational biologic, or investigational
device treatment within 30 days or 5 half-lives, whichever is longer, prior to Visit
2/Baseline.
11. Subject has a history of prescription drug abuse, or illicit drug use within 6 months
prior to Visit 1/Screening.
12. Subject has a history of alcohol abuse according to medical history within 6 months
prior to Visit 1/Screening.
13. Subject has a positive screen for alcohol or drugs of abuse at Visit 1/Screening or
Visit 2/Baseline.
14. Subject has a donation or blood collection of more than 1 unit (approximately 450 mL)
of blood (or blood products) or acute loss of blood during the 90 days prior to Visit
2/Baseline.
15. A. Subject has used systemic inhibitors or inducers of CYP3A4 and Pgp (including
rifampicin, rifabutin, St. John's Wort, corticosteroids, and environmental exposure)
within 30 days prior to dosing at Visit 2/Baseline. B. Subject drank grapefruit juice
within 7 days prior to dosing at Visit 2/Baseline.
16. Subject has used systemic prescription medications, herbals (including herbal teas and
garlic extracts) supplements within 14 days prior to dosing at Visit 2/Baseline.
17. Subject has used systemic over the counter (OTC) medications or vitamins within 7 days
prior to dosing at Visit 2/Baseline. (Note: Use of acetaminophen at < 3g/day is
permitted until 24 hours prior to dosing at Visit 2/Baseline).
18. Subject has used any scalp hair growth treatments including medical devices (e.g., LED
caps/wands/combs), prescription products (e.g., minoxidil, finasteride, dutasteride,
etc.), herbal, homeopathy or other forms of treatment which may affect hair growth (in
the opinion of the investigator) within 14 days prior to dosing at Visit 2/Baseline.
|
