Ph 1, Single-Center, Safety, Tolerability & Pharmacokinetic Study of KX2 391 Ointment in Subj. w Actinic Keratosis

Inclusion Criteria

• •1. Subject is at least 18 years old
• •2. Subject has a clinical diagnosis of stable, clinically typical AK
• •3. Subject has a treatment area on 1 dorsal forearm that in:
• •Cohort 1:
• •* Is one contiguous area
• •* Measures 25 cm2
• •* Contains 4 to 8 AK lesions that are clinically typical.
• •Cohort 2:
• •* Is one contiguous area
• •* Measures 100 cm2
• •* Contains 8 to 16 AK lesions that are clinically typical.
• •4. All women of childbearing potential (WOCBP) must be:
• •* Post-menopausal, defined as at least 50 years of age with amenorrhea for at least 18 months, or
• •* Surgically sterile, defined as having undergone a hysterectomy, bilateral oophorectomy or tubal ligation, or otherwise incapable of pregnancy.
• •* Pre or perimenopausal and practicing a highly effective method of birth control, including hormonal prescription, oral contraceptives, contraceptive injections, contraceptive patch, and intrauterine device, for the duration of their participation in the study. Abstinence and double-barrier methods do not qualify as highly effective methods of birth control.
• •* All woman of child-bearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day 1 (Visit 2) prior to administration of KX2-391 Ointment dose.
• •Contraception
• •* Contraception must be consistently used for at least 3 months prior to screening to 3 months after the last KX2-391 Ointment dose.
• •* Male Contraception: All men who are sexually active with female partners of child bearing potential must agree to ensure their partners use highly effective contraception and therefore will not father a child from screening to 3 months after the last dose of study medication.
• •* Male and Female Contraception: All men and women subjects must agree to not donate sperm or eggs or attempt conception from screening to 3 months after the last KX2-391 Ointment dose.
• •5. Subject is, in the opinion of the investigator, in good general health based on medical history, physical examination, electrocardiogram (ECG), and clinical laboratory evaluations at screening.
• •6. Subject has clinically acceptable liver function at screening as demonstrated by:
• •* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2x upper limit of normal (ULN)
• •* Total bilirubin ≤ ULN
• •7. No other screening laboratory test, including CBC results, considered clinically significant by the investigator
• •8. Subject is not lactating
• •9. Subject is willing and able to follow all study instructions and to attend all study visits
• •10. Subject is able to comprehend and willing to sign an Informed Consent Form (ICF)