Manhattan Begins Dosing in First Phase I Clinical Trial for Oleoyl Estrone

Manhattan Pharmaceuticals has begun dosing patients in its first Phase I trial in Basel, Switzerland, to evaluate the safety and tolerability of defined doses of orally administered Oleoyl estrone (OE) in obese adults.

The objective of this human Phase I dose-escalation study is to determine the pharmacokinetic profile of OE, as well as its safety and tolerability in obese adult volunteers of both genders. In total, 36 obese volunteers will be randomized to receive a single dose of either OE or a placebo, in a dose-escalating manner.

The Swiss medical regulatory authority, SwissMedic, issued its formal approval to initiate such a trial last month. The trial is being conducted under the investigational new drug application recently accepted by the FDA, and the results will be used as a part of the U.S. regulatory approval process.