A Phase IIa Study to Determine the Safety, Tolerability and Absorption of Ha44 Gel Administered Topically to the Hair and Scalp of Subjects with Head Lice

Hatchtech Pty Ltd, 205-211 Grattan Street, Parkville VIC, 3052AUSTRALIATel: +6138344 3190, Fax: +6139347 58880 个研究点目标入组 60 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•Male and female subjects who meet all of the following criteria can be entered into the study:
•1. Diagnosis of head lice infestation
•2. Age 18 to 50 years inclusive.
•3. Body weight at least 45 kg for male subjects and 40 kg for female subjects.
•4. Female subjects must use two forms of contraception (e.g. a hormonal contraception and barrier method contraception or two barrier methods [for females not on a hormonal contraceptive]) or vasectomy (> 6 months) or post-menopausal (no menses for > 2 years) documented for either the subject or their partner, from screening until study completion.
•5. At least five live lice observed.
•6. At least 5 louse eggs that appear viable, no more than 1 cm from the scalp.
•7. In good health, with no major chronic diseases.
•8. Informed consent obtained from subject.

•Subjects who meet any of the following criteria will not be eligible for participation in this study:
•1. Pregnant or breast-feeding females.
•2. A history of scalp eczema.
•3. Any current dermatological disease, including eczema, dermatitis, alopecia.
•4. Current eye disease including allergic or infectious conjunctivitis.
•5. 12-lead ECG demonstrating QTc > 450 msec for women or > 430 msec for men at screening, history or evidence of long QT syndrome or any other clinically significant ECG abnormality.
•6. Treatment with a pediculicide or over-the-counter medicated shampoo within the last 2 weeks.
•7. A known history of allergy or sensitivity to shampoo, hair conditioner or permethrin.
•8. Treatment with medication in the last 7 days. This does not include acetaminophen (paracetamol), ibuprofen and over the counter non-steroidal anti-inflammatory drugs which are permitted up to 2 days before treatment when used as per labeled recommendations. Oral contraceptives are also permitted.
•9. Previous treatment with an investigational agent within the last 30 days, and/or current participation in another clinical study.
•10. Any condition which, in the opinion of the Investigator, would prevent satisfactory participation in the study.

发起方

Hatchtech Pty Ltd, 205-211 Grattan Street, Parkville VIC, 3052AUSTRALIATel: +6138344 3190, Fax: +6139347 5888