Date: 2012-06-19
Type of information:
phase: 1
Announcement: halting of the trial
Company: AstraZeneca (UK) Palatin Technologies (USA)
Product: AZD2820
Action
mechanism: AZD2820 is a subcutaneously-administered peptide melanocortin-4 receptor partial agonist under development by AstraZeneca from a collaborative research program with Palatin Technologies. In 2007, Palatin Technologies entered into an exclusive research collaboration and license agreement with AstraZeneca to discover, develop and commercialize compounds that target melanocortin receptors. Active development work by Palatin under the collaboration portion of the agreement concluded in January 2010.
Disease: obesity
Therapeutic area: Metabolic diseases
Country:
Trial
details: The phase I single center study, conducted by AstraZeneca, targeted enrolling 72 obese but otherwise healthy male subjects, with a body mass index between 30 and 35 kg/m2, in a randomized, single-blind, placebo-controlled, trial. Eleven subjects had completed their dosing regimen prior to the halting of the trial. The primary outcome of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD2820 after administration of multiple ascending doses. Another Phase 1 single ascending dose study of AZD2820 was finalized in 2011 without any reported serious adverse events.
Latest
news: Palatin Technologies has announced that a Phase I clinical trial being conducted by AstraZeneca of AZD2820, a clinical candidate under development for the treatment of obesity.
The Phase 1 clinical trial of AZD2820 was halted by the Safety Review Committee established by AstraZeneca after meeting a predefined stopping criterion. The stopping criterion was a serious adverse event. It is suspected that the subject may have had an allergic reaction following his first dose. The subject was treated at the clinical site and has fully recovered. A review and investigation of the incident has commenced.
