Rock Creek gets UK MHRA nod to begin Phase I trial of Anatabine Citrate

Compared to other anti-inflammatory drugs available such as biologics, steroids and non-steroidal anti-inflammatory drugs, Anatabine Citrate has a distinct anti-inflammatory mode of action.

The three-part Phase I trial is designed to determine the pharmacokinetic profiles of selected modified release formulation prototypes, as well as to evaluate safety and tolerability in healthy subjects.

Part 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 seven to 14 days.

The company said that the six drug formulations planned for testing in part one differ from each other in terms of dose and duration of action.

Part three is a double-blind, placebo-controlled, seven- day multiple dose trial of the optimal formulation in healthy subjects.

Rock Creek Pharmaceuticals CEO Dr Michael Mullan said: "This is the first clinical phase for our lead drug and will focus on safety and tolerability of six different formulations, five of which have modified release profiles and are of different doses. We look forward to generating our first human clinical data under this CTA."

The company’s UK-based outsourced partner Quotient Clinical will immediately start enrolling healthy volunteers, with dosing scheduled to begin in February 2015, and with initial formulation PK data to emerge shortly after.

As part of the trial, Quotient will employ its Rapid Formulation development And Clinical Testing (RapidFACT) service to accelerate the development of these new, oral, modified release formulations that have been co-developed between the two companies.