Rock Creek Pharmaceuticals, Inc. announced that the United Kingdom'sMedicines Healthcare Products Regulatory Agency has approved a clinical trial application to commence a Phase I study of the Company's lead compound, Anatabine Citrate. The Company's lead compound has an anti-inflammatory mode of action distinct from other anti-inflammatory drugs available such as biologics, steroids and non-steroidal anti-inflammatory drugs. The Company's Phase I trial is comprised of a three-part study to determine the pharmacokinetic profiles of selected modified release formulation prototypes, and to evaluate safety and tolerability in healthy subjects.

Parts one and two will both enroll 14 healthy subjects and are designed as open-label, non-controlled, single-dose studies of six different formulations with each dose separated by 7-14 days. The 6 drug formulations planned for testing in part one differ from each other in terms of dose and duration of action. Testing each in turn will allow determination of which formulations have the most acceptable release and safety profiles.

Part three is a double-blind, placebo-controlled, seven- day multiple dose study of the optimal formulation in healthy subjects. As per the trial design, outcome measures will focus primarily on overall safety and tolerability through physical examination, vital signs, clinical chemistry, hematology, urinalysis and observation of adverse events. Secondary outcome measures will include standard pharmacokinetics parameters and also pharmacodynamic assessment, specifically measuring the impact of the drug on inflammatory processes.