Project Title: Collaboration for Innovation: Establishment of a pan-nematode drug development Platform.
Project Description: The work is arranged and will be performed based on Work Packages (WP) and each package has a lead partner as well as collaborating partners. IHI will mainly undertake tasks under WP 9 – WP 15 and is a lead partner for WP 10. The consortium before any activities of WP 9 commerce, must provide to the commission service an updated analysis of the Oxfendazole global development landscape a phase 1 clinical trial for Oxfendazole... The work is arranged and will be performed based on Work Packages (WP) and each package has a lead partner as well as collaborating partners. IHI will mainly undertake tasks under WP 9 – WP 15 and is a lead partner for WP 10. The consortium before any activities of WP 9 commerce, must provide to the commission service an updated analysis of the Oxfendazole global development landscape a phase 1 clinical trial for Oxfendazole (i.e WP9, WP10, WP11) cannot start before the explicit approval of the PO, based on the update provided. To evaluate the safety and tolerability of Oxfendazole in a standard phase 1 single-dose escalation (SAD) design including food effect, that will take place at a single site in Tanzania. Objective 10.1: the primary objective of this study is to perform a SAD study design investigating the safety and tolerability of Oxfendazole after single oral doses administered as a solution in healthy male subjects. Objective 10.2: The secondary objective is to investigate the pharmacokinetics of Oxfendazole after a single oral dose is administered as solution. WP10 – Phase 1 Clinical Trial (Oxfendazole), Lead IHI, partners: Swiss TPH, DNDi) The study will be conducted by IHI in a single in Tanzania, specializing in phase 1 studies. Swiss TPH will manage the conduct of the clinical trial (data management and statistics, monitoring of the study conduct on site and remotely to ensure GCP compliance and adherence to applicable laws and to guarantee patient safety and data integrity medical monitoring, safety reporting to ethics committee(s) and regulatory authority) Swiss TPH under task 10.4 will subcontract PK/PD modeling and ECG analysis. Task 10.1 Site Initiation & Site Opening – A site initiation visit will be prepared and performed by Swiss TPH in order to make sure that the required infrastructure and documentation is in place and to train on all study-related procedures. When these requirements are fulfilled, the site will be formally opened for recruitment. Study design: Standard phase I SAD design including food effect. The study will be performed as a blinded, randomized, placebo-controlled, parallel-group, single dose-escalation comparison study investigating the safety, tolerability, and PK of Oxfendazole after oral administration in healthy male subjects in a single site, specializing in Phase 1 studies. The design of the SAD study is to include 6 cohorts, each consisting of 6 participants receiving Oxfendazole and 2 participants receiving a placebo. Five different doses will be tested; food effects will be assessed in a sixth cohort. Task 10.3: Site close-out Visit: - Once all data are cleaned and the database has been locked, a close-out visit will be conducted to terminate all on-site activities and to prepare for archiving of the study documentation. Task 10.4: Outsourcing of analysis- ECG analysis as well as PK/PD modelling will be outsourced to specialized subcontractors. The outsourcing activities will be managed and coordinated by Swiss TPH. A final report will be prepared at the end. Potential Deliverables D10.1: Midterm recruitment report (Oxfendazole). An n overview will be given after 50% of subjects have been recruited at Phase 1 Clinical Trial Site. D10.2: Study completion report (Oxfendazole). A report outlining the recruited patients, a notification letter will be issued once the last subject had performed his/her last visit; data transmitted to beneficiary 1 for analysis in WP11
Principal Investigator : Said Jongo
Department Name :
Time frame: (2019-09-01) - (2026-02-28)
European Union (EU) Horizon 2020 (Normal)
External Collaborating Partners
Swiss Tropical and Public Health Institute (SwissTPH