Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000408684
Ethics application status
Approved
Date submitted
8/09/2005
Date registered
14/09/2005
Date last updated
20/08/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Safety and pharmacokinetic study of ACV1, a potential neuropathic pain treatment.
Scientific title
A Randomised, Placebo-Controlled, Double-Blind, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous Doses of ACV1 in Healthy Adult Male Subjects.
Secondary ID [1] 164 0
Metabolic Pharmaceuticals Ltd.: METACV101
Secondary ID [2] 165 0
CM6605
Universal Trial Number (UTN)
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neuropathic pain 516 0
Condition category
Condition code
Neurological 593 593 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomised, placebo-controlled, double-blind, single and mutliple (7 day) ascending dose, Phase 1 study of subcutaneous ACV1 in healthy adult male volunteers.
Intervention code [1] 416 0
Treatment: Drugs
Comparator / control treatment
Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 688 0
Safety of both single and multiple subcutaneous doses of ACV1 when administered to healthy adult male volunteers. The data available for review includes clinical lab tests, vital signs, ECGs and adverse events
Timepoint [1] 688 0
Collected to a minimum of 24 hours post-dose for single dose groups and 7 days for multiple dose groups.
Primary outcome [2] 689 0
Tolerability of both single and multiple subcutaneous doses of ACV1 when administered to healthy adult male volunteers. The data available for review includes clinical lab tests, vital signs, ECGs and adverse events
Timepoint [2] 689 0
Collected to a minimum of 24 hours post-dose for single dose groups and 7 days for multiple dose groups.
Secondary outcome [1] 1423 0
To determine the pharmacokinetics of both single and multiple doses of subcutaneous ACV1.
Timepoint [1] 1423 0
Up to 24 hours post-dose.
Secondary outcome [2] 1424 0
To determine the pharmacodynamic effects of ACV1 when administered subcutaneously.
Timepoint [2] 1424 0
This will be assessed during the multiple-dose groups by evaluation of touch sensitivity using Von Frey filaments on Day 1 and Day 6 pre-dose, and up to 8 hours post-dose.
Secondary outcome [3] 1425 0
An electrical stimulation test will be carried out during the multiple dosing.
Timepoint [3] 1425 0
Pre-dose on Day 1, and pre-dose and up to 8 hours post-dose on Days 2 and 7.

Eligibility
Key inclusion criteria
Weight <= 100 kg, BMI 19 to 30, generally healthy, adequate venous access, fluent English, have given written informed consent.
Minimum age
18 Years
Maximum age
49 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Hypersensitivity, medical conditions, organ dysfunction, drug or alcohol abuse, taking medication.

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)
Vials containing the drug are numbered with a patient ID number to conceal treatment allocation. Formulations are provided in ready-to-administer syringes so medical and nursing staff remind blind.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random allocation was carried out manually. Treatment assignment ensures that within each dose group only one subject receives placebo and four subjects receive active treatment.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/06/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 199 0
5000

Funding & Sponsors
Funding source category [1] 647 0
Commercial sector/Industry
Name [1] 647 0
Metabolic Pharmaceuticals Ltd
Country [1] 647 0
Australia
Funding source category [2] 2500 0
Government body
Name [2] 2500 0
Ausindustry
Country [2] 2500 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Metabolic Pharmaceuticals Ltd.
Address
Level 3, 509 St Kilda Rd
Melbourne
VIC 3004
Country
Australia
Secondary sponsor category [1] 543 0
None
Name [1] 543 0
N/A
Address [1] 543 0
Country [1] 543 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1794 0
CMAX - Clinical (a division of IDT Australia)
Ethics committee address [1] 1794 0
Level 5 East Wing
Royal Adelaide Hospital
North Terrace
Adelaide 5000
Ethics committee country [1] 1794 0
Australia
Date submitted for ethics approval [1] 1794 0
17/07/2006
Approval date [1] 1794 0
18/08/2006
Ethics approval number [1] 1794 0
CM6605

Summary
Brief summary
The primary purpose of this study is to assess the safety and tolerability of subcutaneous doses of ACV1 in healthy adult males.
Trial website
www.metabolic.com.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36389 0
Address 36389 0
Country 36389 0
Phone 36389 0
Fax 36389 0
Email 36389 0
Contact person for public queries
Name 9605 0
Dr Caroline Herd
Address 9605 0
Metabolic Pharmaceuticals Ltd
Level 3
509 St Kilda Rd
Melbourne VIC 3004
Country 9605 0
Australia
Phone 9605 0
+61 3 98605700
Fax 9605 0
+61 3 98605777
Email 9605 0
[email protected]
Contact person for scientific queries
Name 533 0
Dr Caroline Herd
Address 533 0
Metabolic Pharmaceuticals Ltd
Level 3
509 St Kilda Rd
Melbourne VIC 3004
Country 533 0
Australia
Phone 533 0
+61 3 98605700
Fax 533 0
+61 3 98605777
Email 533 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
SourceTitleYear of PublicationDOI
EmbaseAdvances in venom peptide drug discovery: where are we at and where are we heading?.2021https://dx.doi.org/10.1080/17460441.2021.1922386
N.B. These documents automatically identified may not have been verified by the study sponsor.