A clinical phase IIa randomized, ascending dose, placebo-controlled, assessor-blind, safety, tolerability and efficacy study of orally administered Moxidectin in subjects with microfilaraemic Loa loa infection

Bernhard Nocht Institut for Tropical Medicine0 个研究点目标入组 165 人开始时间: 2023年2月8日最近更新: 2023年5月29日

适应症

试验速览

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•Both sexes, Aged 18 to 65 years, inclusive
•Body weight = 40 kg
•Good general condition, as determined by the medical questionnaire and clinical examination
•Hematological parameters and adequate renal and hepatic functions, such as:
•oLeukocytes = 3,000 and = 11,300 cells/ml
•oHemoglobin = 8.0 g/dl
•oPlatelets =75,000/mm3
•oSerum creatinine = 2.5 x ULN
•oTotal bilirubinemia = 1.5 x ULN
•oALT = 3.0 x ULN
•oAST = 3.0 x ULN
•oNegative urinary strip: absence of leukocyturia, hematuria, and proteinuria (in case of positivity, a second urinary strip test will be made for con-firmation)
•Blood microfilarial density 1-1,000/ml or 1,000-2,000/ ml according to the recruit-ment cohort, respectively
•Written, signed and dated informed con-sent of participant or impartial witness
•Ability to take oral treatment and willing-ness to comply with the study procedures (covered by the informed consent)

•Ongoing participation in any interventional trial.
•Any vaccination within 2 weeks before study drug administration
•Acute infection requiring antibiotic therapy within the last 10 days before study drug administration
•Concomitant administration of drugs of the benzodiazepine class (s. Annex)
•Known past or current history of neurolog-ical or neuropsychiatric disease or epilepsy (incl. previous meningitis, encephalitis)
•History of drug or alcohol abuse
•Any condition, in the investigator's opinion, that places the subject at undue risk
•Subjects who have donated blood within 8 weeks before study entry
•Antifilarial therapy within the previous year (DEC, IVM, albendazole for more than 7 days)
•History of severe drug-induced hypersensi-tivity reaction during previous medical treatment or mild to moderate hypersensi-tivity reaction to macrolytic lactones
•Known intolerance to IVM, MOX or any of the excipients (including placebo)
•Pregnant and breastfeeding women

发起方

Bernhard Nocht Institut for Tropical Medicine