NCT02989194已完成2 期
A Phase 2a Double-blind, Placebo-controlled Study to Assess the Safety and Tolerability of a Single Intravenous Dose of an Investigational Monoclonal Antibody With Code Name VIS410 in Subjects With Uncomplicated Influenza A Infection
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 主要终点
- Assess the Safety and Tolerability of a Single IV Dose of VIS410 in Participants With Uncomplicated Influenza Infection
研究概览
简要总结
This is a Phase 2a randomized, double-blind, placebo-controlled study designed to assess the safety and tolerability of an investigational monoclonal antibody, VIS410, in subjects with uncomplicated influenza.
详细描述
Subjects will be admitted to an infusion unit for drug administration and observation following infusion. The study is designed to compare an infusion of a single high or low IV dose of VIS410 against placebo. Subjects will be followed for 100 (±7 days).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 否
入选标准
- •Male and female subjects aged ≥18 years and ˂65 years
- •Women should fulfill one of the following criteria:
- •Post-menopausal; either amenorrhea ≥12 months or follicle stimulating hormone >40 mIU/mL (milli-international units/milliliter) as documented in their medical history
- •Surgically sterile; hysterectomy, bilateral oophorectomy, or tubal ligation
- •Women of childbearing potential participating in heterosexual sexual relations must be willing to use adequate contraception from screening until 60 days post infusion
- •Non-vasectomized (or vasectomized less than 6 months prior to dosing) male subjects who have a female partner of childbearing potential must use an effective birth control method when having heterosexual intercourse, from screening until 60 days post infusion
- •Test positive for influenza A by Rapid Antigen Test performed with a commercially available test on an adequate nasopharyngeal specimen in accordance with the manufacturer's instructions
- •Presence of at least one respiratory symptom (cough, sore throat, or nasal symptoms) of moderate to severe intensity, or presence of at least one constitutional symptom (myalgia [aches and pains], headache, feverishness, or fatigue) of moderate to severe intensity
- •Onset of symptoms (time when the temperature was first measured as elevated [temperature of ≥100.4°F or ≥38°C], OR the time when the subject experienced at least one respiratory symptom or at least one constitutional symptom) no more than 72 hours before the start of infusion
排除标准
- •Use of NSAIDs or antihistamines within 6 hours of study drug dosing with the exception of those used as part of the pretreatment regimen
- •History of intolerance or allergic response to monoclonal antibodies and/or pretreatment medications (diphenhydramine, ibuprofen and acetylsalicylic acid)
- •Subject weight less than (<) 45 kg
- •Subjects with clinical history that would lead to increased risk of influenza complications including but not limited to clinically significant cardiac disease, moderate to severe asthma, or other moderate to severe chronic obstructive pulmonary disease, metabolic syndrome including moderate to severe diabetes or active tuberculosis
- •History of chronic GI disease, including bleeding, ulceration, Irritable Bowel Syndrome, systemic mastocytosis or chronic diarrhea
- •Women who are pregnant, breast-feeding, or considering becoming pregnant
- •Patients with hypoxemia requiring oxygen support
- •Clinical evidence of worsening of any chronic medical condition (temporally associated with the onset of symptoms of influenza) which, in the Investigator's opinion, indicates that such finding(s) could represent complications of influenza
- •Presence of immunocompromised status due to chronic illness, previous organ transplant, or use of immunosuppressive medical therapy including systemic steroids
- •Presence of known Acquired Immune Deficiency Syndrome-defining illness, chronic hepatitis B or hepatitis C
- •Receipt of any dose of antiviral therapy such as, but not limited to, rimantadine, amantadine, peramivir, zanamivir, laninamivir or oseltamivir in the 7 days prior to screening
- •Enrollment in any other investigational drug or device study, any disease or vaccine study within 30 days prior to Day 1 or within 5 half-lives of the investigational compound, whichever is longer
- •Subjects unable to take oral predose medication
- •Known or suspected alcohol or drug abuse, that is, abuse of a level that would compromise the safety or cooperation of the subject in the opinion of the Investigator
- •Subjects on chronic medications where the dose has not been stable for at least 3 months
研究组 & 干预措施
VIS410 low dose
Experimental
Single intravenous fixed low dose of VIS410
干预措施: VIS410 low dose (Drug)
VIS410 high dose
Experimental
Single intravenous fixed high dose of VIS410
干预措施: VIS410 high dose (Drug)
Placebo
Placebo Comparator
Single intravenous placebo infusion
干预措施: Placebo (Drug)
结局指标
主要结局
Assess the Safety and Tolerability of a Single IV Dose of VIS410 in Participants With Uncomplicated Influenza Infection
时间窗: 100 days
The percentage of participants with adverse events (AEs) and serious adverse events (SAEs) following administration of a single dose of IV VIS410.
Percentage of Participants With Any Treatment-emergent Adverse Event (TEAE) and TEAEs of Special Interest
时间窗: 100 days
Percentage of participants experiencing any TEAE, TEAEs considered related to study treatment and the number of participants experiencing adverse events of special interest (AESI). A TEAE is defined as an adverse event that starts on or after the date of study drug IV infusion. AESIs included hypersensitivity reaction, anaphylactic reaction, or injection site adverse event.
次要结局
- Clearance (CL) of VIS410 in Serum.(1, 3, 5, 7, 14, 28, 56, 100 days)
- Peak Viral Load by TCID50(7 days)
- Time to Resolution of Peak Viral Load From Nasopharyngeal Samples by TCID50.(7 days)
- Percentage Change From Baseline in Signs and Symptoms of Influenza-like Illness as Assessed by the Influenza Patient Reported Outcomes Questionnaire After a Single IV Dose of VIS410(10 days)
- Influenza A Relapse/Reinfection(100 days)
- VIS410 Plasma Concentration (AUC 0-last)(1, 3, 5, 7, 14, 28, 56, 100 days)
- Half-life of VIS410 in Serum.(1, 3, 5, 7, 14, 28, 56, 100 days)
- Area Under the Viral Load-Time Curve (VL AUC) From Nasopharyngeal Swab Day 7.(7 days)
- Summary of Anti-VIS410 Antibody (ADA) Titers.(100 days)
- Duration of Signs and Symptoms of Influenza-like Illness as Assessed by the Influenza Patient Reported Outcomes Questionnaire After a Single IV Dose of VIS410(10 days)
- Hospitalization for Influenza-related Complications(100 days)
- Count of Participants With Complications of Influenza(100 days)
- VIS410 Maximum Plasma Concentration(1, 3, 5, 7, 14, 28, 56, 100 days)
- Pharmacokinetics of VIS410 Concentration in Serum(1, 3, 5, 7, 14, 28, 56, 100 days)
- Duration of Hospitalization for Complications of Influenza(100 days)
- VIS410 Plasma Concentration ( AUC 0-infinity)(1, 3, 5, 7, 14, 28, 56, 100 days)
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