Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000014459
Ethics application status
Approved
Date submitted
4/01/2007
Date registered
9/01/2007
Date last updated
19/09/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
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
Scientific title
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
Universal Trial Number (UTN)
Trial acronym
Ha01-001
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy subjects 1515 0
Condition category
Condition code
Other 1613 1613 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ha44 is a novel insect ovicide. It is a lotion (0.37% or 0.74%) which is applied topically to the hair and scalp as a single dose at the start of the study. The lotion is washed off after 10 or 20 minutes.
Four groups will be studied, each group consisting of 8 subjects, 6 of whom will be treated with Ha44 and 2 with vehicle only. The vehicle onsists of a number of excipients, all of which are listed on the FDA database of inactive ingredients and within the allowed concentrations.
The first group will be treated with 0.37% Ha44 or vehicle for 10 minutes. After review of 7 day safety data, a second group will be treated with 0.37% Ha44 or vehicle for 20 minutes. After review of their 7 day safety data, a third group will be treated with 0.74% Ha44 or vehicle for 10 minutes. After review of 7 day safety data, a fourth group will be treated with 0.74% Ha44 or vehicle for 20 minutes.
Intervention code [1] 1534 0
Treatment: Drugs
Comparator / control treatment
Lotion constituents without Ha44 active
Control group
Placebo

Outcomes
Primary outcome [1] 2225 0
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.
Timepoint [1] 2225 0
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 [1] 3879 0
Plasma levels of Ha44 after topical application.
Timepoint [1] 3879 0
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.
Secondary outcome [2] 3880 0
Urine levels of Ha44 after topical application.
Timepoint [2] 3880 0
Urine Ha44 will be measured pre-dose and at 1, 2, 4, 8, 12, 24 hours after administration.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
All study personnel, including study coordinators, nursing staff, physicians and analysts will be blinded at all times to the study treatments.
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/01/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1759 0
Commercial sector/Industry
Name [1] 1759 0
Hatchtech Pty Ltd
Country [1] 1759 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Hatchtech Pty Ltd
Address
205 - 211 Grattan Street
PO Box 4192
Parkville VIC 3052
AUSTRALIA
Country
Australia
Secondary sponsor category [1] 1559 0
None
Name [1] 1559 0
Nil
Address [1] 1559 0
Country [1] 1559 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3283 0
Q-Pharm Pty lmited
Ethics committee address [1] 3283 0
Ethics committee country [1] 3283 0
Australia
Date submitted for ethics approval [1] 3283 0
Approval date [1] 3283 0
08/12/2006
Ethics approval number [1] 3283 0
QIMR No H0612-052T(P1047)

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27468 0
Address 27468 0
Country 27468 0
Phone 27468 0
Fax 27468 0
Email 27468 0
Contact person for public queries
Name 10723 0
Dr Suzanne Elliot
Address 10723 0
Q-Pharm Pty Limited
PO Box 78
Royal Brisbane Hospital
QLD 4029
Country 10723 0
Australia
Phone 10723 0
+61 7 38453644
Fax 10723 0
+61 7 38453637
Email 10723 0
[email protected]
Contact person for scientific queries
Name 1651 0
Dr Lewis Schulz
Address 1651 0
Hatchtech Pty Ltd
205 - 211 Grattan Street
PO Box 4192
Parkville VIC 3052
Country 1651 0
Australia
Phone 1651 0
+61 3 83443194
Fax 1651 0
+61 3 93475888
Email 1651 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.