NCT05474755已完成3 期
A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study on the Safety and Efficacy of GP681 Tablets in the Treatment of Acute Uncomplicated Influenza
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 591
- 试验地点
- 1
- 主要终点
- Time to alleviation of influenza symptoms
研究概览
简要总结
This study will evaluate the efficacy, safety, and population pharmacokinetics of a single, oral dose of GP681 compared with placebo in patients aged 12 to 65 years with acute uncomplicated influenza virus infection
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 5 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged≥5 to≤65 years at the time of signing the informed consent form.
- •Patients with a diagnosis of influenza confirmed by all of the following:
- •Positive Influenza rapid antigen test or Polymerase chain reaction (PCR), and;
- •Fever (axillary temperature ≥37.3℃) in the predose examinations or > 4 hours after dosing of antipyretics if they were taken,and;
- •At least one of the following systemic symptoms and respiratory symptoms respectively associated with influenza are present with a severity of moderate or greater:
- •Systemic symptoms: headache, fever or chills, muscle or joint aches, fatigue;
- •Respiratory system symptoms: cough, sore throat, nasal congestion.
- •The time interval between the onset of symptoms and random enrollment is 48 hours or less. The onset of symptoms is defined as either:
- •Time of the first increase in body temperature (axillary temperature ≥37.3℃)
- •Time when the patient experiences at least one systemic or respiratory symptom related to influenza
- •Subjects of child-bearing potential who agree to use a highly effective method of contraception for 1 month after drug withdrawal.
- •Subjects and/or their guardian who are willing to provide written informed consent and consent to participate in the study, able to understand the study and comply with all study procedures, including patient health diary records.
排除标准
- •History of allergic reactions attributed to GP681 or any of the ingredients of its formulation.
- •Patients with influenza virus infection requiring inpatient treatment;
- •Known history of dysphagia or any gastrointestinal disease that affects drug absorption (including but not limited to reflux esophagitis, chronic diarrhea, inflammatory bowel disease, intestinal tuberculosis, gastrinoma, short bowel syndrome, stomach after subtotal resection, etc.).
- •Treatment with anti-influenza virus drugs (oseltamivir, zanamivir, peramivir, favipiravir, arbidol, baloxavir marboxil, amantadine, or rimantadine) within 2 weeks before screening, or immunization with influenza vaccine within 6 months prior to enrollment;
- •Investigator suspects or confirms that patients with bronchitis, pneumonia, pleural effusion or interstitial disease through chest imaging examination.
- •Acute respiratory infection, otitis media or sinusitis within 2 weeks prior to Screening.
- •Patients with concurrent bacterial or (non-influenza) infections requiring systemic antimicrobial and/or antiviral therapy at the pre-dose examinations.
- •Positive nucleic acid test for COVID-19 in screening period.
- •Patients with severe or uncontrollable underlying diseases, including blood disorders, severe chronic obstructive pulmonary disease(COPD), liver disorders, kidney disorders, chronic congestive heart failure(NYHA III-IV), mental disorders;
- •Immunodeficiency,including malignant tumor, organ or marrow transplant, human immunodeficiency virus [HIV] infection, or patients receiving immunosuppressant therapy 3 months prior to enrollment.
- •Concomitant therapy with aspirin or salicylic acid.
- •Morbid obesity (Body mass index [BMI]≥30kg/m2)
- •Women who are pregnant, breastfeeding, or have a positive pregnancy test at the predose examinations. The following female patients who have documentation of either a or b below do not need to undergo a pregnancy test at the predose examinations:
- •Postmenopausal women (defined as cessation of regular menstrual periods for 2 years or more and aged more than 50 years old)
- •Women who are surgically sterile by hysterectomy, bilateral oophorectomy, or tubal ligation
- •Known history of alcohol abuse (Average weekly intake of alcohol is more than 14 units alcohol (1 units ≈ 360 mL beer, or 45 mL spirits with 40% content, or 150 mL wine) or drug abuse at screening;
- •Patients weighing <20 kg.
- •Has received any investigational agents or devices for any indication within 30 days prior to Screening.
- •Patients who, in the opinion of the Investigator, may not be qualified or suitable for the study.
研究组 & 干预措施
GP681 40mg
Experimental
Patients in the GP681 40mg group will receive a single oral dose of GP681 tablet 40mg with 240mL water.
干预措施: GP681 40mg (Drug)
placebo group
Placebo Comparator
Patients in the Placebo group will receive a single oral dose of GP681 Simulant 40mg with 240mL water.
干预措施: Placebo (Drug)
结局指标
主要结局
Time to alleviation of influenza symptoms
时间窗: Up to Day 15
Participants assessed the severity of seven influenza-associated symptoms (cough, sore throat, headache, nasal congestion, feverishness or chills, muscle or joint pain, and fatigue) on a 4-point scale (with 0 indicating no symptoms, 1 mild symptoms, 2 moderate symptoms, and 3 severe symptoms). Defined as the time from the start of treatment until the patient's body temperature returns to normal and all 7 flu symptoms (cough, sore throat, headache, nasal congestion, fever or chills, muscle or joint pain, fatigue) have alleviated (scoring 0 or 1 point) for at least 21.5 hours.
次要结局
- Area Under the Concentration (AUC) of virus RNA by RT-PCR and AUC of virus titer(Up to Day 7)
- Change From Baseline in Virus RNA (RT-PCR) at Each Time Point(Days 2, 3, 5,7)
- Time to Cessation of Viral Shedding Determined by Virus Titer(Up to Day7)
- Percentage of Participants With Positive Influenza Virus RNA by RT-PCR at Each Time Point(Days 2, 3, 5,7)
- Percentage of Participants With Positive Influenza Virus Titer at Each Time Point(Days 2, 3, 5,7)
- Change in the total score of 7 influenza symptoms(Up to Day15)
- Time to alleviation of each influenza symptom(Up to Day15)
- Time to Alleviation of the Four Systemic Symptoms in Participants(Up to Day15)
- Time to Alleviation of the Three Respiratory Symptoms in Participants(Up to Day15)
- Percentage of Participants Reporting Normal Temperature at Each Time Point(12, 24, 48, 72, 96,120, 144 and168 hours after the initial dose of study treatment)
- Time to Resolution of Fever(Up to Day15)
- Incidence of Influenza-related Complications(Up to Day15)
- Proportion of Patients and Frequency in Combination Use of Acetaminophen(Up to Day15)
- Time to Return to Normal Activities of Daily Life(Up to Day15)
- Change from baseline in health-related quality of life according to EuroQol 5 dimensions 5 (EQ-5D-5L) questionnaire(Up to Day15)
研究者
研究点 (1)
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