Preliminary Phase I safety data with British Biotech's stem cell chemokine BB-10010 has shown the product to be well tolerated at all doses, reports the company.
In this Phase I study, single rising doses of BB-10010 or placebo were administered to 36 healthy adults in a randomized, double-blind, placebo-controlled manner. The drug was administered in two different forms (intravenous and subcutaneous) in order to define the optimum route for the product.
Both routes of administration were well tolerated, but the subcutaneous injection provided the additional benefit of maintaining measurable blood levels over a 24- hour period. Although the intravenous injections of BB-10010 produced initially higher levels of the drug, they declined more rapidly. The company says that it is therefore concentrating on the subcutaneous route for the drug development program in patients.
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