NCT04941183终止1 期
A Randomized, Placebo-controlled, Double-blind, Single-ascending-dose and Multiple-ascending-dose, Phase 1 Study to Assess the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of IV NTR-441 Solution in HV Adults and COVID-19 Patients
Neutrolis4 个研究点 分布在 2 个国家目标入组 52 人开始时间: 2021年4月14日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 52
- 试验地点
- 4
- 主要终点
- To evaluate safety and tolerability of single and multiple ascending doses of NTR-441 solution administered intravenously (IV) to adults
研究概览
简要总结
This first-in-human clinical study is a Phase 1a/ 1b, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, and PK/PD of NTR-441 in healthy subjects and patients with COVID-19 after single ascending IV infusion doses and multiple ascending IV infusion doses.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Male or female, non-smoker, ≥18 and ≤55 years of age, with Body Mass Index (BMI) > 18.5 and < 32.0 kg/m2
- •Healthy with no clinically significant findings, determined by medical evaluation (medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations) at Screening
- •Subject is able to understand and is willing to comply with all study requirements, and willing to follow the instructions of the study staff.
- •Subject voluntarily agrees to participate in this study.
排除标准
- •Pregnancy, nursing, and/or breastfeeding.
- •Study participant has a history of an anaphylactic reaction.
- •Subject has used an investigational drug within 30 days (or 5 half-lives whichever is longer) prior to the first dose of study drug.
- •Has received any prescription or nonprescription over-the-counter (except occasional use of acetaminophen, paracetamol or ibuprofen) medication, topical medications, vitamins, dietary or herbal during the last 14 days or 5 half-lives, whichever is longer.
- •Subject has a positive urine test for drugs of abuse at the screening visit or admission.
- •Regular consumption of alcohol within 6 months prior to Screening or use of illicit substances within 3 months prior to screening.
- •Subject has positive test for SARS-CoV-2 infection, human immunodeficiency virus (HIV), chronic or active hepatitis B, or active hepatitis C.
- •Donation or loss of blood or plasma within 4 weeks prior to initial dosing.
- •Subject has a history or current evidence of a serious and/or unstable cardiovascular, respiratory, gastrointestinal, hematologic, autoimmune, mental or other medical disorder, including cirrhosis or malignancy; a history of a psychiatric disorder that will affect the subject's ability to participate in the study.
- •Subject has a clinically relevant abnormal ECG; abnormal laboratory values.
- •Subject has hypertension.
- •COVID-19 patients:
- •Inclusion Criteria:
- •Male or female, non-smoker, ≥18 years of age.
- •Participant has active laboratory-confirmed SARS-CoV-2 infection.
- •Participant must be hospitalized for COVID-19 pneumonia.
- •Ability to provide informed consent personally, or by a legally acceptable representative if the participant is unable to do so.
- •Exclusion Criteria:
- •Pregnancy, nursing, and/or breastfeeding.
- •History of an anaphylactic reaction.
- •In the opinion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments.
- •Severely immune-compromised participants.
- •Participant known to test positive for human immunodeficiency virus (HIV), chronic or active hepatitis B, or active hepatitis C.
- •Any other clinical conditions that in the opinion of the Investigator would make the participants unsuitable for the study.
- •Prior treatment with any investigational drug therapy against coronavirus infection within 5 half-lives, prior to enrollment
- •Participants who have received an experimental (or, in future, potentially a licensed) immunization or remdesivir against coronavirus remain eligible.
- •Participation in another clinical study with the study intervention administered from 30 days or 5 half-lives whichever is longer.
- •Anticipated transfer to another hospital which is not a study site during the intervention period.
研究组 & 干预措施
NTR-441
Experimental
Single Ascending Dose; Multiple Ascending Dose.
干预措施: NTR-441 (Drug)
Placebo
Placebo Comparator
Single Ascending Dose; Multiple Ascending Dose.
干预措施: Placebo (Drug)
结局指标
主要结局
To evaluate safety and tolerability of single and multiple ascending doses of NTR-441 solution administered intravenously (IV) to adults
时间窗: 60 days
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 following a single or multiple IV of NTR-441.
次要结局
- To assess for immunogenicity of NTR-441 following single ascending and multiples ascending doses of NTR-441 solution administered IV to adults(30 days)
- Measurement of terminal elimination half-life (t½)(15 days)
- Measurement of maximum plasma concentration (Cmax)(15 days)
- Measurement of time of maximum plasma concentration (Tmax)(14 days)
- Measurement of area under the concentration-time curve(15 days)
- Measurement of the terminal elimination rate (λz)(15 days)
- Measurement of total body clearance (CL/F)(15 days)
- Measurement of apparent volume of distribution(15 days)
研究者
研究点 (4)
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