Safety of a Single Dose of Moxidectin Compared With Ivermectin in Individuals Living in Onchocerciasis Endemic Areas

• Status: Recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this phase 3b study is to determine the safety of a single dose of moxidectin, compared to a single dose of ivermectin, in individuals living in an onchocerciasis endemic area.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Medicines Development for Global Health
• Treatments: Ivermectin; Milbemycin; Moxidectin

Criteria

Inclusion Criteria:

• Provision of written informed consent, or assent with parental or guardian written consent

• Known O. volvulus skin microfilariae density ≥0 microfilariae/mg skin

• Living in an onchocerciasis endemic area.

• Age ≥ 12 years.

• All female participants of childbearing potential must commit to the use of a reliable method of birth control until 3 months after administration of investigational product (Month 3)

Exclusion Criteria:

• Pregnant or breast-feeding.

• Any concurrent condition that, in the opinion of the Investigator, would preclude evaluation of response to treatment or would pose undue risk to the participant's health.

• Has received ivermectin or oral diethylcarbamazine (DEC) within 30 days of Baseline.

• Has received treatment with an investigational agent within the 30 days (or 5 half-lives, whichever is longer) prior to planned investigational product administration.

• Known or suspected allergy to ivermectin or moxidectin or their excipients.

• Self-reported planned or ongoing activities within the study period that would make it unlikely that the participant will be available for follow-up examinations.

• Infection with Loa loa