PACTR202010898529928招募中2 期
A Phase-II, Randomised, Double-blind, Parallel-group Trial to Investigate Emodepside (BAY 44-4400) in Subjects with Onchocerca volvulus Infection, comprising: Part 1 to Investigate Safety, Tolerability, Pharmacodynamics, Pharmacokinetics and Dose-Response Relationship for Efficacy (Proof-of-Concept); Part 2 to Investigate Efficacy of Selected Doses, Safety, Tolerability and Pharmacokinetics
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 578
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19 Year(s) 至 44 Year(s)（—）
- 性别
- All
入选标准
- •Main Inclusion Criteria
- •1.Written, signed (or thumb-printed) and dated informed consent
- •2.Men and women 18 to 65 years of age with Onchocerca volvulus infection
- •a.Presence of at least 1 excisable subcutaneous nodule/onchocercoma detected on palpation
- •b.O. volvulus infection diagnosed by skin snip method, documented skin assessment on 4 skin snips.
- •c.Body weight at Screening > 40 kg
- •3.For women of child-bearing potential (WOCBP), acceptance of the requirement to use a highly effective form of birth control
排除标准
- •Main Exclusion Criteria
- •1.Administration of medication or herbal therapies as follows:
- •i.The following antifilarial therapies or medication that may have an antifilarial effect:
- •ivermectin, = 6 months prior to IMP administration,
- •doxycycline, = 1 year prior to IMP administration, more than 2 weeks course,
- •moxidectin, = 2 years prior to IMP administration.
- •ii.Other preventive chemotherapy, e.g. as part of an MDA programme within 14 days prior to IMP administration.
- •2.Presence of any clinically significant medical condition at Screening: including, but not limited to diabetes type 1 or 2; past or current history of neurological or neuropsychiatric disease or epilepsy; sickle cell disease; known human immunodeficiency virus (HIV) infection, disclosed by review of medical history or concomitant medication.
- •3.Presence of abnormal physical findings or laboratory values at Screening that could interfere with the objectives of the trial or the safety of the subject, in the opinion of the Investigator.
- •4.Known hypersensitivity to any ingredient of the IMP, including the active ingredient emodepside, or to ivermectin, or to any medication used during the study.
- •5. Current hyperreactive onchodermatitis or severe manifestations due to onchocerciasis.
- •6.Coincidental infection with other endemic filarial parasites based on laboratory tests at Screening (Wuchereria bancrofti, Mansonella spp.).
- •7.Coincidental infection with Loa loa based on medical history or positive test at Screening.
- •8.In groups intended to include subjects without ocular involvement: ocular microfilariae or onchocercal eye lesions, assessed at Screening.
- •9.Ophthalmological history or conditions that could make the ocular examination difficult or represent a risk for the safety of the subject.
- •10.For WOCBP: Pregnancy or breastfeeding
研究者
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