A Single/Multiple Ascending Dose Phase 1 Study Of The Safety, Tolerability, And Pharmacokinetics Of Intranasal 2-Deoxy-D-Glucose In Normal Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Adverse drug reactions (ADRs)
研究概览
简要总结
2-DG-01 is a randomized, double-blind, placebo-controlled, single and multiple ascending dose phase 1 study assessing safety, tolerability and pharmacokinetics of 2-DG in normal healthy volunteers (NHV). The safety and pharmacokinetics of 2-DG are assessed after single or multiple intranasal administrations.
详细描述
2-DG-01 is a randomized, placebo-controlled, double- blind single and multiple ascending dose phase 1 study in normal healthy male and female volunteers aged 18 years or older.
The primary objective of this study is to assess the clinical safety and tolerability of intranasal 2-DG in NHVs.
The secondary objective of this study is to assess the human pharmacokinetics of 2-DG.
The study is divided in two sub-parts: Part A, a single ascending dose (SAD) study of 2-DG and Part B, a multiple ascending dose (MAD) study.
Part A consists of 3 cohorts: Cohorts 1 and 2 with a randomization ratio for 2-DG to placebo of 4:1 and Cohort 3 with a randomization ratio for 2-DG to placebo of 8:2.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female volunteers, age ≥ 18 years old at screening
- •Females must be post-menopausal (> 1 year since last menstruation)
- •Able to comprehend and to give informed consent
- •Able to cooperate with the investigator, to comply with the requirements of the study, and to complete the full sequence of protocol-related procedures
- •Undergone full immunisation against SARS-CoV2 or status post infection with SARS-CoV2 (both as defined by the Austrian Ministry of Health)
排除标准
- •Frequent epistaxis (equal to or greater than 1/month)
- •Hypo- or anosmia
- •Symptoms of rhinitis, allergy or common cold disease at screening and at study initiation
- •Medical history of diabetes mellitus of any type
- •Clinically relevant abnormal findings at screening
- •Preceding nasal surgery or sinus surgery
- •Medical history of allergic rhinitis or chronic condition of the upper or lower respiratory tract with active symptoms within 30 days prior to screening
- •SARS-CoV-2 infection positive by PCR test at screening
- •Vulnerable subjects as defined by GCP
- •Subjects in a dependency relationship towards the investigators, e.g. as employees
- •Substance abuse, mental illness, or any reason that makes it unlikely in the judgment of the investigator for the subject to be able to comply fully with study procedures
- •Use of medication (including prophylactic treatments) during 2 weeks before the start of the study, which in the judgment of the investigator may adversely affect the subject's welfare or the integrity of the study's results
- •Concurrent treatment with other experimental product or participation in another clinical trial with any investigational product within 30 days or 5 elimination half-lives (whichever is longer) prior to treatment start
- •Scheduled vaccination appointments during the study period
研究组 & 干预措施
Study drug
Each subject receives either a single dose (SAD) or a multiple dose (MAD) of a 3.5% 2-Deoxyglucose as nasal spray solution.
The starting dose for the first cohort is 3.5 mg/day up to a maximum of 84 mg/day at cohort 6.
干预措施: 2-Deoxyglucose (Drug)
Placebo
Each subject receives either a single (SAD) or multiple (MAD) dose of placebo. The dose for each cohort is corresponding the amount of solution needed in the verum group.
干预措施: Placebo (Other)
结局指标
主要结局
Adverse drug reactions (ADRs)
时间窗: until 168 hours after start of multiple drug dosing
Number of ADRs after multiple doses of 2-DG assessed by type, frequency and severity of ADRs graded as per Common Terminology Criteria for Adverse Events (CTCAE).
次要结局
- Biodistribution of multiple doses of 2-DG(baseline, 12 hours, 15 hours, 24 hours, 72 hours, 168 hours after start of multiple drug dosing)
- Premature terminations due to ADRs after a single dose of 2-DG(until 24 hours after single drug dosing)
- Biodistribution of a single dose of 2-DG(baseline,0.5 hours, 2 hours, 4 hours, 6 hours after single drug dosing)
- Local tolerability of a single dose of 2-DG(baseline, 6 hours, 24 hours after single drug dosing)
- Local tolerability of multiple doses of 2-DG(baseline, 3 hours, 12 hours, 24 hours after start of multiple drug dosing)
- Olfactory function after a single dose of 2-DG(baseline, 24 hours after single drug dosing)
- Olfactory function after multiple doses of 2-DG(baseline, 24 hours, 72 hours, 168 hours after start of multiple drug dosing)
- Premature terminations due to ADRs after multiple doses of 2-DG(until 168 hours after start of multiple drug dosing)
- Adverse events after single dose 2-DG(until 24 hours after single drug dosing)
- Adverse events after multiple doses 2-DG(until 168 hours after start of multiple drug dosing)