2023-509311-91-01已完成2 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.
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- The difference in the rate of rhinovirus-associated illness between 2-DG and placebo
研究概览
简要总结
To confirm the efficacy of 2-DG compared to placebo for the prevention of rhinovirus-associated illness.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 是
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
结局指标
主要结局
The difference in the rate of rhinovirus-associated illness between 2-DG and placebo
The difference in the rate of rhinovirus-associated illness between 2-DG and placebo
次要结局
- Difference in Total Jackson Symptom Score
- Difference in number of infected subjects (defined by laboratory-confirmed infection)
- Difference in % of infected subjects (defined by laboratory-confirmed infection)
- Difference in Duration of Illness between the groups, days 2-15
- Occurrence of adverse events (AEs) and adverse drug reactions (ADRs)
研究者
G. Gualdoni
Scientific
G.ST Antivirals GmbH
研究点 (1)
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