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

Phase 1

Completed

• Conditions: Healthy subjects; Other - Research that is not of generic health relevance and not applicable to specific health categories listed above

• Registration Number: ACTRN12607000014459
• Lead Sponsor: Hatchtech Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-01-09
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of Ha44 after topical application. Safety will be assessed by physical examination, including detailed assessment of scalp, face, eyes and ears, vital signs, 12-lead electrocardiogram, laboratory tests including haematology, clinical chemistry and urinalysis and adverse events.[Assessments will be made 10, 20, 45 minutes, 1, 2, 4, 8, 12 and 24 hours, 7-10 days and 25-31 days after application.]

Secondary Outcome Measures

Name	Time	Method
Plasma levels of Ha44 after topical application.[Plasma Ha44 will be measured pre-dose on the day of the study and at 15, 30, 45 minutes, 1, 2, 4, 8, 12 and 24 hours.];Urine levels of Ha44 after topical application.[Urine Ha44 will be measured pre-dose and at 1, 2, 4, 8, 12, 24 hours after administration.]