Safety and pharmacokinetic study of ACV1, a potential neuropathic pain treatment.
Phase 1
Completed
- Conditions
- europathic painNeuropathic painNeurological - Other neurological disorders
- Registration Number
- ACTRN12605000408684
- Lead Sponsor
- Metabolic Pharmaceuticals Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 60
Inclusion Criteria
Weight <= 100 kg, BMI 19 to 30, generally healthy, adequate venous access, fluent English, have given written informed consent.
Exclusion Criteria
Hypersensitivity, medical conditions, organ dysfunction, drug or alcohol abuse, taking medication.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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[Collected to a minimum of 24 hours post-dose for single dose groups and 7 days for multiple dose groups.];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[Collected to a minimum of 24 hours post-dose for single dose groups and 7 days for multiple dose groups.]
- Secondary Outcome Measures
Name Time Method To determine the pharmacokinetics of both single and multiple doses of subcutaneous ACV1.[Up to 24 hours post-dose. ];To determine the pharmacodynamic effects of ACV1 when administered subcutaneously. [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. ];An electrical stimulation test will be carried out during the multiple dosing.[Pre-dose on Day 1, and pre-dose and up to 8 hours post-dose on Days 2 and 7.]