CTIS2023-509311-91-01招募中1 期
A randomized, double-blind, placebo-controlled Phase 2 study using the rhinovirus challenge model to investigate the efficacy and safety of 2-Deoxy-D-glucose as pre-exposure prophylaxis. - 2-DG-02
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 128
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 年龄范围
- 18 至 64（—）
- 性别
- All
入选标准
- •Healthy male or female subjects 18 to 64 (inclusive at screening) years of age. The investigator judges the definition of healthy by detailed medical history and physical examination, Women of childbearing potential and all males must practice effective contraception during the study and be willing and able to continue contraception for at least 90 days after their last dose of study treatment, Signed informed consent form prior to any study-related procedures, Subject is willing and able to tolerate the nasal wash procedure at screening, Has the ability to communicate well with the investigator in the Dutch language and the willingness and ability to adhere to the prohibitions and restrictions specified in this protocol
排除标准
- •Active smoker or history of smoking > 5 pack years, Upper or lower respiratory tract infection or febrile illness (temperature = 37.9 °C), in the period of 2 weeks prior to study drug administration., Presence (at screening) of serum RV-39 neutralizing antibody titer at greater than one in four (1:4) dilution, Prior inoculation with a virus from the same virus family as the challenge virus, Hypersensitivity/allergy to any of the investigational product ingredients
研究者
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