R-Tech Ueno, Ltd. Completes Phase 1 Clinical Study...( TOKYO July 21 /- R-Tech Ueno Lt...),Health

TOKYO, July 21 /PRNewswire/ -- R-Tech Ueno, Ltd. announced on July 17 that as a phase 1 clinical study on the new compound RK-023 that is being developed by our company as a therapeutic drug of androgenetic alopecia (male pattern baldness; see the note below) has been completed.

The phase 1 clinical study of RK-023 consisted of a patch test (open, closed, photo-patch test), single-dose study and 5-day repeated-dose study. Since no serious adverse event occurred in each test, RK-023 seems to hardly cause any safety problem in the human body.

As the first step, patch tests were conducted to obtain data on skin irritation. Using RK-023 preparation and a placebo, the tests were conducted on 20 healthy adult males by the following 3 methods and the results were evaluated.

    (1) Open patch test: Open patch dressing to the forearm skin for 48 hours
    (2) Closed patch test: Closed patch dressing to the back skin for 48 hours
    (3) Photo-patch test: Closed patch dressing to the back skin for 24 hours,
        followed by UVA irradiation

No adverse event occurred and the resulting irritation was negligible in each test.

As the next step, single and 5-day repeated applications of RK-023 preparation to the scalp were conducted by a randomized, placebo-controlled, double blind method to evaluate the safety and pharmacokinetics of the drug. In the single-dose study, 2 ml of RK-023 preparation was applied to the vertex region of 6 out of 9 healthy adult males and a placebo to that of the remaining 3 subjects. The applied drug was spread widely covering the vertex region in order to investigate the safety in the entire body and scalp. No serious adverse event occurred. After application of the drug, blood and urine were collected in the lapse of time to determine drug concentrations. However, the drug concentration was below the quantification li
'/>"/>