NCT06375772终止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
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 64
- 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
2-DG-02 is a randomized, placebo-controlled, double-blind Phase 2 study to investigate the efficacy and safety of 2-Deoxy-D-Glucose as a pre-exposure prophylaxis using the rhinovirus challenge model in healthy study participants.
详细描述
2-DG-02 is a randomized, placebo-controlled, double-blind Phase 2 study using the rhinovirus challenge model in healthy study participants aged 18 to 64 years.
The primary objective is to confirm the efficacy of 2-DG compared to placebo for the prevention of rhinovirus-associated illness.
Secondary objectives are
- to evaluate the effect of 2-DG on the occurrence and course of rhinovirus infection
- to evaluate the effect of 2-DG on the severity of symptoms of rhinovirus infection
- to evaluate safety and tolerability of 2-DG administrated over 1 week in the presence of rhinovirus exposure
- to evaluate pharmacokinetics of 2-DG
128 subjects, who have been pre-screened and found to be seronegative to rhinovirus type 39, are randomized 1:1 to either 2-DG (pre-exposure prophylaxis) or placebo the day prior to inoculation. Subjects receive 2-DG or placebo starting from the day prior to inoculation until 5 days post inoculation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 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.
- •Women of childbearing potential and all males must practice effective contraception during the study and be willing and able to continue contraception until end of study.
- •Signed informed consent form prior to any study-related procedures.
排除标准
- •Active smoker or history of smoking > 5 pack years.
- •Upper or lower respiratory tract infection or febrile illness
- •Presence (at screening) of serum RV-39 neutralizing antibody titer at greater than one in four (1:4) dilution.
- •Nasopharyngeal swab indicative for Influenza or SARS-CoV2 infection by rapid antigen test at baseline.
- •Prior inoculation with a virus from the same virus family as the challenge virus.
- •Any anatomic or neurologic abnormality impairing the gag reflex, or associated with an increased risk of aspiration, or any abnormality significantly altering the anatomy of the nose or nasopharynx in a substantial way that may interfere with the aims of the study and in particular any of the nasal assessments or viral challenge.
- •Positive Hepatitis B surface antigen (HBsAg), Hepatitis C virus antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab) at screening.
- •Any confirmed or suspected disease or condition associated with immune system impairment, including auto-immune diseases, asplenia or recurrent severe infections.
- •Active allergic rhinitis or hay fever.
- •Medical history or active asthma or chronic obstructive pulmonary disease (COPD) or any other pulmonary disease deemed by the investigator to increase the risk of participating in the study.
- •Active nasal disease, e.g., nasal polyposis, significant septal deviation, chronic rhinosinusitis, etc.
- •Frequent epistaxis or nasal sinus surgery within 3 months before baseline.
- •Females: Pregnant, breast-feeding or intentions to become pregnant during the study.
- •Evidence or history of drug or alcohol abuse.
- •Positive test for drugs of abuse at screening or prior to study drug administration.
- •Use of any prescribed or non-prescribed medication (except for contraceptives, paracetamol) within 1 week or less than 5 half-lives (whichever is longer) prior to the first administration of investigational product.
- •Use of any over the counter cold prophylaxis products including nasal sprays, C-vitamins, zinc or Echinacea within 2 weeks prior to the first administration of investigational product.
- •Participation in an investigational medical product, vaccine or device study within 3 months or 5 half-lives prior to the study period (whichever is longer), or more than 4 times in the past year.
- •Hypersensitivity/allergy to any of the investigational product ingredients.
- •Individuals with close contact to at risk patient group (infants less than 3 years, the extremely elderly >80 years or infirm, pregnant women, patients with severe lung disease(e.g., asthma/cystic fibrosis (CF)/COPD), patients with primary or secondary immunodeficiencies or ongoing immunosuppressive therapy).
- •Any clinically relevant abnormal history, physical finding, 12-lead safety ECG, vital signs, laboratory value at screening or any known factor that could interfere with the objectives of the trial or the safety of the volunteer. In the case of uncertain or questionable results, tests performed during screening may be repeated before inclusion to confirm eligibility or judged to be clinically irrelevant.
研究组 & 干预措施
Study Drug
Active Comparator
Each subject receives a multiple dose of a 3.5% 2-Deoxyglucose as nasal spray solution. The maximum daily dose is 56 mg/day if applied 4 times/day, over 7 days.
干预措施: 2-Deoxy-D-glucose (Drug)
Placebo
Placebo Comparator
Each subject receives a multiple dose of placebo as nasal spray solution. The dose is corresponding to the amount of solution needed in the serum group.
干预措施: Placebo (Other)
结局指标
主要结局
The difference in the rate of rhinovirus-associated illness between 2-DG and placebo
时间窗: baseline until day 22
Difference in the rate of symptomatic illness and laboratory-confirmed infection
次要结局
- Difference in percent of days virus positive(days 2-6)
- Difference in peak nasal virus load(days 2-6)
- Difference in AUC nasal virus load(days 2-6)
- Difference in Total Jackson Symptom Score(days 2-6 after start of dosing)
- Duration of illness(days 2-15 after start of dosing)
- Difference in percent of days Jackson Symptom Score positive(days 2-6 after start of dosing)
- Difference in Peak Jackson Symptom Score(days 2-6 after start of dosing)
- Number of infected subjects(baseline, days 2-22 after start of dosing)
- Difference in percent of infected subjects(baseline, days 2-22 after start of dosing)
- Difference in peak total WURSS-21(days 2-6 after start of dosing)
- Difference in AUC total WURSS-21(days 2-6 after start of dosing)
- Biodistribution of multiple doses of 2-DG in nasal wash samples(baseline, days 2-6 and day 22± 2 after start of dosing)
- Occurrence of adverse events (AEs) and adverse drug-reactions (ADRs)(from screening (day -56) until end of study (day 22± 2) after start of dosing)
- Biodistribution of multiple doses of 2-DG in plasma samples(baseline, days 6 and 22± 2 after start of dosing)
研究者
研究点 (1)
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