Metabolic is pleased to announce that dosing in the ACV1 Phase 1 human clinical trial commenced on schedule today in Adelaide, South Australia. Metabolic’s innovative pain drug is being developed in response to a serious need for new pain killers with novel modes of action. The drug (ACV1) has thus far demonstrated in animal studies that it reduces neuropathic (nerve) pain, appears to accelerate the functional recovery of damaged nerves, and is well tolerated. The Phase 1 study is the first time ACV1 has been administered to humans. This is a randomised, double-blind, placebo-controlled Phase 1 study. The main aims are to assess the safety, tolerability, and pharmacokinetics of both single doses and multiple (7) daily doses of ACV1 administered by subcutaneous injection in healthy, male volunteers. Up to six dose levels from 5 micrograms per kg to 400 micrograms per kg will be evaluated in both the single ascending dose and multiple ascending dose parts of the study. At each dose level five different subjects will be studied; four subjects will be randomised to receive the active ACV1 drug and one subject will be randomised to receive placebo (a solution without the active drug) for comparison. The multiple ascending dose administrations will follow the initial single ascending dose part of the study. Volunteers will be monitored for a range of safety parameters while resident in the clinical study unit. In addition, blood samples will be collected for the measurement of ACV1 levels to ascertain the pharmacokinetics of the drug i.e. information on the way the drug is absorbed, distributed and eliminated from the body. The trial is expected to be finished by the end of 2005. A positive outcome would allow Phase 2 safety and efficacy trials in patients suffering from neuropathic pain to be conducted in 2006.
MBP Price at posting:
0.0¢ Sentiment: None Disclosure: Not Held
