The US Food and Drug administration (FDA) has removed clinical hold on the US Naval Medical Research Center’s (NMRC) investigational new drug (IND) application enabling initiation of a clinical trial evaluating a hyperimmune product to prevent infectious diarrhoea.
NMRC has addressed all clinical hold issues that were identified by the FDA, satisfactorily.
Developed in collaboration with Immuron, the oral therapeutic will be assessed for its safety and protective efficacy in preventing infectious diarrhoea caused by Campylobacter and Enterotoxigenic Escherichia coli (ETEC).
The placebo-controlled, randomised study will examine two inpatient cohorts (cohort 1 ETEC or cohort 2 C) of 60 subjects in two controlled human Phase II infection-model trials of new Campylobacter ETEC therapeutic.
One trial will focus on the ability of the product to prevent infectious diarrhoea caused by ETEC while the second on protecting volunteers against moderate to severe campylobacteriosis.
Including 30 healthy participants aged 18-50 years, the first study will be conducted at the Johns Hopkins University’s (JHU) Center for Immunization Research (CIR) inpatient unit at the Johns Hopkins Bayview Medical Campus.
These participants will include males or non-pregnant, non-nursing females.
Details about the second study have not been disclosed.
The most common illness, infectious diarrhoea is reported by travellers visiting developing countries and US troops deployed overseas.