Clinical development

Safety studies in human volunteers

Single ascending dose safety and pharmacokinetics study

ODG members worked with the National Institutes of Health (NIAID/DMID) to conduct First in Human studies of oxfendazole, the first clinical step in the development of oxfendazole. The design and results of this safety and pharmacokinetics study are given under NCT02234570 on the ClinicalTrials.gov web site: https://clinicaltrials.gov/ct2/show/NCT02234570?term=oxfendazole&rank=2  The results of the Phase I Single Ascending Dose (SAD) study of oxfendazole are now published.  See the safety profile and pharmacokinetics of oxfendazole in healthy volunteers: publication Phase I SAD study

Multiple ascending dose safety and pharmacokinetics study and food effect study

ODG is working with the National Institutes of Health (NIAID/DMID) in the conduct a multiple ascending dose safety and pharmacokinetics study of oxfendazole, as well as a food effect study. The design of these studies is given under NCT03035760 on the ClinicalTrials.gov web site: https://clinicaltrials.gov/ct2/show/NCT03035760?term=oxfendazole&rank=2  This study has been successfully completed, and its results will shortly be accessible on ClinicalTrials.gov at the above link.

Efficacy study in patients

Proof of concept study in patients

ODG holds an open IND for a Proof of Concept study of oxfendazole in patients infected with the geohelminth Trichuris trichiura, an intestinal worm. In this assessor blind, randomized Phase 2 study, the efficacy of different doses of oxfendazole will be compared to the efficacy of albendazole, the currently used medication. Albendazole is only moderately effective in curing T. trichiura infection. The design of this study is given under NCT03435718 on the Clinicaltrials.gov website: https://clinicaltrials.gov/ct2/show/NCT03435718?term=oxfendazole&rank=1