A Phase I, Single Centre, Double Blind, Randomised, Placebo Controlled, Single Escalating Dose Study to Determine the Safety, Tolerability and Absorption of Ha44 Administered Topically to the Hair and Scalp of Healthy Volunteers

Hatchtech Pty Ltd0 个研究点目标入组 32 人开始时间: 2007年1月9日最近更新: 2020年1月13日

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•Female subjects must be of non-childbearing potential and/or have a negative pregnancy test prior to study start and be deemed not at risk of becoming pregnant. Females of child bearing age who are sexually active must use two forms of contraception from screening until study completion Non smoker. Full head of hairMaximum hair length no more than 6 cmBody mass index between 18 and 28 kg/m2 inclusive, with body weight between 60-100 kgIn good health, as determined by screening assessmentsAble to provide written informed consent.

•Pregnant or breast-feeding femalesSubjects with a history of skin sensitisation or skin allergiesSubjects with abraded or abnormal skin on the area to be tested Subjects with any dermatological disease, including eczema, dermatitis, alopeciaSubjects who have taken any prescribed systemic or topical medication within two weeks prior to dosing, except for females on the contraceptive pill. Subjects who have taken any non-prescribed systemic or topical medication, except vitamins, within two weeks prior to dosing. Evidence of illicit drug use, as determined by a urine drug screenHistory of alcohol abuse Subjects with a known allergy to any of the components of the formulationPrevious treatment with an investigational agent within the last 30 daysAny condition which, in the opinion of the investigator, would prevent satisfactory participation in the study.

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