PACTR202104600961505尚未招募2 期
A Phase-II, Randomised, Double-blind, Parallel-group, Proof-of-concept Trial to Investigate ABBV-4083 given for 7 or 14 Days or in Combination with Albendazole in Subjects with Onchocerca volvulus Infection, comprising:Part 1 to Investigate Safety, Tolerability, Efficacy for Dose-Ranging and Pharmacokinetics;Part 2 to Investigate Efficacy of Selected Doses, Safety, Tolerability and Pharmacokinetics
Drugs for Neglected0 个研究点目标入组 444 人开始时间: 2021年4月12日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 444
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
- •1. Written, signed (or thumb-printed) and dated informed consent.
- •2. Men and women with Onchocerca volvulus infection, 18 to 65 years of age inclusive at time of Screening:
- •i. Presence of at least one excisable subcutaneous nodule/onchocercoma detected on palpation;
- •ii. O. volvulus infection diagnosed by skin snip method: documented mf-positivity on skin assessment on at least 2 out of 4 skin snips.
- •3. Body weight > 40 kg at Screening.
- •4. For women of child-bearing potential, acceptance of requirement to use highly effective birth control from Day 0 until at least 1 month after the final intake of IMP.
排除标准
- •Main exclusion criteria
- •1. Administration of medication or herbal preparations as follows:
- •i. Any medication or herbal preparation within 14 days prior to IMP administration;
- •ii. Strong CYP3A inhibitors or inducers within 14 days or 10 half-lives, whichever is longer, prior to IMP administration.
- •iii. Other drugs known to interact with albendazole, within 14 days or 10 half-lives, whichever is longer, prior to IMP administration;
- •iv. The following antifilarial therapies, or medication that may have an antifilarial effect: • ivermectin; = 6 months prior to IMP administration;
- •and/or • doxycycline, = 1 year prior to IMP administration: more than 2-week course;
- •and/or • any other anti-Wolbachia treatments, = 1 year prior to IMP administration: more than 2-week course;
- •and/or • moxidectin, = 2 years prior to IMP administration;
- •v. Other preventive chemotherapy, e.g. as part of an MDA program, within 14 days prior to IMP administration;
- •2. Requirement for albendazole during the first 28 days after IMP administration or more than one dose per year thereafter given in MDA;
- •3. Presence of any of the following at Screening:
- •i. Abnormal physical and/or neurological examination or laboratory findings;
- •ii. Any clinically significant medical condition including, significant acute or chronic liver or kidney condition or cardiovascular disease, active infection, current or previous epilepsy, known human immunodeficiency virus (HIV) infection, disclosed by review of medical history or concomitant medication;
- •4. Ophthalmological history or conditions that could interfere with the objectives of the trial or the safety of the subject.
- •5. Clinically significant history of cardiac abnormality, and/or relevant pathological abnormalities on the ECG at Screening.
- •6. Known hypersensitivity to any ingredient of the IMPs, including the active ingredient of ABBV-4083, macrolides, albendazole or to ivermectin or to any medication used during the study (e.g. for eye examination).
- •7. Coincidental infection with other endemic filarial parasite (Loa loa > 8 000 mf/mL, Mansonella species or Wuchereria bancrofti), based on positive laboratory test at Screening.
- •8. Current hyperreactive onchodermatitis or severe manifestation due to onchocerciasis.
- •9. For women of child-bearing potential: pregnant or breastfeeding.
研究者
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