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.
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