NCT05277350已完成1 期
A Phase 1, Randomized, Double-Blind, First-In-Human, Dose Escalation Study Investigating the Safety, Recovery, and Pharmacodynamics of Multiple Oral Administrations of SNIPR001 in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Safety and tolerability as measured by incidence and severity of AEs and Medically Attended Adverse Events (MAAEs) from the first administration of study drug and up until Day 35 of the study.
研究概览
简要总结
This is a Phase 1, randomized, double-blind, placebo-controlled, multiple dose, dose escalation study in healthy participants, investigating the safety, tolerability, recovery, and PD of multiple oral administrations of SNIPR001.
详细描述
Approximately 36 healthy male and female participants will be randomized to one of 3 active oral doses of SNIPR001 or matching placebo, administered twice a day (BID) for 7 days. Subjects will be followed up until 6 months after receiving the last dose of SNIPR001.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
double-blind
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent
- •Male or female healthy subject defined as no known clinically relevant organ abnormality, or disease diagnosis, as per Investigator discretion
- •No clinically significant abnormalities indicated by safety laboratory test results
- •Age between 18 years and 65 years
- •E. coli present in feces sample
- •Normal defecation pattern (at least once daily)
- •Willing to participate in the study and provide fecal samples
排除标准
- •Treatment with antibiotics or any other prescription medication within the last 30 days prior to or during screening
- •Use of probiotics (not including dairy products) within the last 30 days prior to or during screening
- •Smoking (cigarettes, pipes, vaping products, etc.) within the last 3 months prior to or during screening
- •6 months prior to or during screening, recent history of alcohol or drug abuse, or current regular alcohol consumption of more than 14 units per week (one unit of alcohol equals one beer (285 ml), one glass of wine (125 ml), or one glass of spirits (25 ml))
- •Positive alcohol or drugs of abuse test
- •Pregnancy or lactating or intention of becoming pregnant (all females to agree to use highly effective contraception (defined as those, alone or in combination, that result in a low failure rate i.e., less than 1% per year) for the entire study duration
- •Obesity as defined by WHO i.e., BMI>32 kg/m2
- •Known to be HIV-positive
- •Known active hepatitis B and/or hepatitis C infection
- •Known congenital or acquired immunodeficiency
- •Allergy to any component of the trial drug and ant-acid treatment
- •Regular use of medications that affect gastrointestinal motility e.g., antidiarrheals, stool softeners and laxatives, GLP-1 analogues
研究组 & 干预措施
Cohort 3
Active Comparator
12 participants on SNIPR001 (Dose 3 BID for 7 days) and 8 participants on placebo
干预措施: Placebo (Drug)
Cohort 1
Active Comparator
6 participants on SNIPR001 (Dose 1 BID for 7 days) and 2 participants on placebo
干预措施: SNIPR001 (Drug)
Cohort 1
Active Comparator
6 participants on SNIPR001 (Dose 1 BID for 7 days) and 2 participants on placebo
干预措施: Placebo (Drug)
Cohort 2
Active Comparator
6 participants on SNIPR001 (Dose 2 BID for 7 days) and 2 participants on placebo
干预措施: SNIPR001 (Drug)
Cohort 2
Active Comparator
6 participants on SNIPR001 (Dose 2 BID for 7 days) and 2 participants on placebo
干预措施: Placebo (Drug)
Cohort 3
Active Comparator
12 participants on SNIPR001 (Dose 3 BID for 7 days) and 8 participants on placebo
干预措施: SNIPR001 (Drug)
结局指标
主要结局
Safety and tolerability as measured by incidence and severity of AEs and Medically Attended Adverse Events (MAAEs) from the first administration of study drug and up until Day 35 of the study.
时间窗: 35 days
次要结局
- Incidence and severity of AEs and MAAEs from Day 35 to Day 187 of the study(152 days)
- Functional quantification of SNIPR001 (recovery) in feces, blood, and urine before, during, and after multiple oral SNIPR001 administrations(187 days)
研究者
研究点 (1)
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相关资讯
Expanded Access Case Report Shows SNIPR001, an Engineered CRISPR Phage Therapy, Associated with 89% Reduction in Multidrug-Resistant E. coli Malakoplakia Mass- A kidney transplant recipient with progressive, multidrug-resistant E. coli malakoplakia received SNIPR001 via intravenous, topical, and intralesional routes under an FDA emergency IND, with no phage-related adverse events reported.
- The intra-abdominal malakoplakia mass decreased from 745 cm³ at baseline to 82 cm³ at one year, an 89% reduction, and follow-up urine and tissue cultures were negative following treatment.
- SNIPR001 is a CRISPR-armed phage therapeutic designed to selectively target E. coli; it is currently in Phase 1b/2a development for preventing bloodstream infections in hematological cancer patients and holds FDA Fast Track designation.
- The case supports further investigation of non-oral delivery for infections outside the gut, though causality cannot be attributed solely to SNIPR001 given concomitant antibiotic therapy.last monthSNIPR's CRISPR-Armed Phage Therapy SNIPR001 Demonstrates Safety in First Human Trial- SNIPR Biome published positive Phase 1 results for SNIPR001 in The Lancet Microbe, marking the first randomized, placebo-controlled trial of an orally administered CRISPR-Cas-armed bacteriophage therapeutic.
- The study demonstrated favorable safety and tolerability across three dose levels in 36 healthy volunteers, with no serious adverse events and restriction to the gastrointestinal tract without systemic exposure.
- SNIPR001 showed a 78% reduction in E. coli levels versus placebo at the highest dose, though the study was not powered for statistical significance on efficacy endpoints.
- The company's ongoing Phase 1b trial in hematological cancer patients undergoing stem-cell transplantation is now more than halfway complete, targeting a high-risk population prone to antibiotic-resistant bloodstream infections.6 months ago