The Phase 1 study is the first clinical study for development of SGX203 (oral beclomethasone 17, 21-dipropionate or oral BDP) against paediatric Crohn’s disease.
The Study BDP-PCD-01 is designed to assess the pharmacokinetic (PK) and pharmacodynamic (PD) profile of oral BDP in healthy young male and female adolescents and adults.
A total of 24 subjects will be enrolled in the study that is expected to be completed in June 2013.
Soligenix senior vice president and chief medical officer Kevin Horgan said SGX203 has the potential to meet an important medical need in children with the serious illness.
"Data from this study will be used to refine the PK model we have established with Dr. Barrett," Horgan added.
"The PK model provides the justification for limited PK sampling in a subsequent clinical study in the pediatric population which is planned to commence later this year."