Efficacy and Safety of Emodepside in Adults Infected With Trichuris Trichiura and Hookworm

Efficacy and Safety of Emodepside in Adults Infected With Trichuris Trichiura and Hookworm: Randomized Two Stages Phase II Seamless Adaptive Controlled Single-blind Trials

The rationale of the study is to provide evidence on the efficacy and safety of Emodepside in adults infected with Trichuris trichiura and hookworm.

Inclusion Criteria:

• Male or female adults aged between 18 and 45 years
• Written and signed informed consent
• Examined by a study physician before treatment
• Provided two stool samples at baseline
• Trichuris trichiura and hookworm EPG ≥ 48 and at least two Kato-Katz thick smears slides with more than one Trichuris trichiura and hookworm eggs

Exclusion Criteria:

• Pregnant or lactating and/or planning to become pregnant within three months after drug treatment
• Type 1 and/or 2 diabetes
• Psychiatric disorders
• History of ophthalmological conditions
• Presence or history of major systemic or chronic illnesses, as assessed by a medical doctor, during initial clinical assessment
• Suffers from severe anaemia (Hb < 80 g/l)
• Received anthelminthic treatment within past four weeks
• Attending other clinical trials during the study
• Received strong CYP3A4 inducers or inhibitors as well as concomitant treatments that are relevant substrate for CYP3A4 such as clarithromycin, erythromycin and rifampicin
• Received strong P-gp inhibitors as well as concomitant treatments that are relevant substrates for P-gp such as clotrimazole and ritonavir