A Phase 1, Randomized, Double-blinded, Vehicle-controlled, Single and Multi-Dose, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics in Healthy Volunteers of the Novel Self-Administered Intranasal CG- SpikeDown Antiviral Drug
试验速览
- 阶段
- 1 期
- 入组人数
- 16
- 主要终点
- SARS Cov-2 RT-PCR test
研究概览
简要总结
Study Design This is a phase 1, randomized, Vehicle-controlled, double-blinded study to assess the safety of Caregen Intranasal CG-SpikeDown in healthy subjects.
All randomized subjects will receive an active drug or Vehicle. Subjects randomized to the DP(Drug product) active treatment will receive CG- SpikeDown intranasally once daily for one or seven days at either a low (25 mg) or planned (50 mg) dose.
Subject recruitment will be conducted via study advertisement on social media, and subjects will be adequately compensated. The subjects will arrive each day at the clinic to receive the treatment and will be hospitalized for safety monitoring for the first 24 hours post-DP or vehicle administration.
详细描述
This is a phase 1, Randomized, Double-blinded, Vehicle-controlled, Single and Multi-Dose, Dose Escalation Study, which will assess the safety of the Caregen CG-SpikeDown drug self-administered intranasally, for healthy subjects.
The study will include 16 healthy subjects and will be conducted in a clinic under complete supervision of the clinical team. The study will start with evaluation of the lowest dose, that will be increased gradually as long as no safety issues arise.
At the first stage of the study, three (3) subjects will be randomized in a 1:2 ratio to receive vehicle treatment or the active drug, respectively. Each of the 3 subjects will receive a single 25 mg dose of the assigned treatment. These subjects will be referred as Cohort 1. If no safety issues arise, the study will proceed simultaneously to the second and third stages, as depicted in Figure 1 Study Flow Chart.
At the second stage of the study, additional three (3) subjects will be enrolled and randomized in a 1:2 ratio to receive vehicle treatment or the active drug, respectively. Each of the 3 subjects will receive a single 50 mg dose of the assigned treatment. These subjects will be referred as Cohort 2. If no safety issues arise, the study will proceed to the 4th stage.
At the third stage of the study, additional three (5) subjects will be enrolled. The first 2 subjects (out of the 5 subjects) will receive an open label DP treatment-a daily 25 mg dose for 7 days. The open-label subjects will undergo PK assessments as described in the SOA. The next 3 subjects will be randomized in a 1:2 ratio to receive vehicle treatment or the active drug, respectively. Each of the 3 subjects will receive a daily 25 mg dose of the assigned treatment for 7 days. These subjects will be referred as Cohort 3.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The study will begin with recruitment for the single 25 mg dose arm /vehicle arm, and once all subjects have been treated and attended their first follow-up visit with no significant safety issues, recruitment of participants for the single 50 mg dose arm/vehicle arm and the multiple 25 mg dose arm/vehicle arm. Once subjects from the multi 25 mg dose Cohort have attended their follow-up visit with no significant safety issues, recruitment for the final multiple 50 mg dose arm/vehicle arm may commence.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
stage I- Healty
The first 2 patients in this stage will receive the vehicle treatment and will not undergo the first 24 hour hospitalization. The 3rd and 4th patients will receive a lower dose of 12.5 mg of the DP once daily for 7 days, and the first 24 hours will be hospitalized for the first 24 hours. The 5th patient will receive the 25 mg from the DP once daily for 7 days and will be hospitalized for the first 24 hours. The next 2 patients will receive the 25 mg dose and will not undergo the first 24 hour hospitalization. The next 3 patients will receive the optimal dose of 50 mg and will not undergo the first 24 hour hospitalization
干预措施: CG-SpikeDown, intranasal formulation (Drug)
Stage II- Placebo + SOC
This arm will be include 20 This arm will be include 20 symptomatic non-hospitalized COVID-19 patients and will be conducted at patients' homes during their self-isolation, and they will be received Placebo + standard of care
干预措施: Vehicle (Placebo) (Drug)
Stage II- Placebo + SOC
This arm will be include 20 This arm will be include 20 symptomatic non-hospitalized COVID-19 patients and will be conducted at patients' homes during their self-isolation, and they will be received Placebo + standard of care
干预措施: Standard of core (type of therapy is depend of decide of the site) (Drug)
Stage II- DP low dose (25 mg) + SOC
This arm will be include 20 symptomatic non-hospitalized COVID-19 patients and will be conducted at patients' homes during their self-isolation, and they will be received Drug product low does(25 mg) + standard of care
干预措施: CG-SpikeDown, intranasal formulation (Drug)
Stage II- DP low dose (25 mg) + SOC
This arm will be include 20 symptomatic non-hospitalized COVID-19 patients and will be conducted at patients' homes during their self-isolation, and they will be received Drug product low does(25 mg) + standard of care
干预措施: Vehicle (Placebo) (Drug)
Stage II- DP low dose (25 mg) + SOC
This arm will be include 20 symptomatic non-hospitalized COVID-19 patients and will be conducted at patients' homes during their self-isolation, and they will be received Drug product low does(25 mg) + standard of care
干预措施: Standard of core (type of therapy is depend of decide of the site) (Drug)
Stage II- DP planned dose (50 mg) + SOC
This arm will be include 20 This arm will be include 20 symptomatic non-hospitalized COVID-19 patients and will be conducted at patients' homes during their self-isolation, and they will be received Drug product planned does(50 mg) + standard of care
干预措施: CG-SpikeDown, intranasal formulation (Drug)
Stage II- DP planned dose (50 mg) + SOC
This arm will be include 20 This arm will be include 20 symptomatic non-hospitalized COVID-19 patients and will be conducted at patients' homes during their self-isolation, and they will be received Drug product planned does(50 mg) + standard of care
干预措施: Vehicle (Placebo) (Drug)
Stage II- DP planned dose (50 mg) + SOC
This arm will be include 20 This arm will be include 20 symptomatic non-hospitalized COVID-19 patients and will be conducted at patients' homes during their self-isolation, and they will be received Drug product planned does(50 mg) + standard of care
干预措施: Standard of core (type of therapy is depend of decide of the site) (Drug)
结局指标
主要结局
SARS Cov-2 RT-PCR test
时间窗: 7 days
Viral load is estimated from nasopharyngeal swabs and instructions for use is based on the package insert of the diagnostic. This assessment will be used to diagnose COVID-19 patients during Stage II in case they do not have a positive COVID-19 test result from 72 hours before the Stage II screening visit, and will also be used to assess viral load in COVID-19 patients during Stage II.
Area under the plasma concentration versus time curve
时间窗: 7 days
The following PK parameters evaluation collected 10 minutes prior to DP self-administration, immediately following DP self-administration, and 1, 2, 4 and 6 hours following DP self-administration, on Day 1 and Day 6 of treatment. These measurements will be collected only during Stage I (from 10 healthy subjects)
次要结局
- NIAID ordinal scale(14 days)
- Peak Plasma Concentration(7 days)