Efficacy and Safety of Emodepside in Adolescents and Adults Infected With Hookworm

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

To compare the efficacy and safety of emodepside to that of albendazole (Zentel®) in participants aged 12-60, inclusive, infected with hookworm.

Inclusion Criteria:

• Male or female adults aged between 12 and 60 years;
• Written and signed informed consent;
• Was examined by a study physician before treatment;
• Provided two stool samples at baseline;
• Hookworm EPG > 48 and at least two Kato-Katz thick smears slides with more than one 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.
• Participated in stage I trials of this protocol