NCT06643156已完成1 期
A Multicenter, Open-label, Single-arm, Exploratory Clinical Study on the Tolerability, Safety and Efficacy of GP681 Powder for Oral Suspension in the Treatment of Uncomplicated Influenza in Pediatric and Adolescent Patients
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Number of Participants with Adverse Events (AEs)
研究概览
简要总结
This study aims to evaluate the tolerability, safety, pharmacokinetic characteristics and efficacy of a single oral dose of GP681 powder for oral suspension in pediatric and adolescent patients with uncomplicated influenza. The study will also explore the optimal dose for a confirmatory clinical trial. Eligible patients who have been confirmed influenza virus infection and have experienced influenza symptoms within 48 hours prior to enrollment, will receive single dose of GP681 powder for oral suspension. The primary outcome measures included the observation of adverse events during the study, the pharmacokinetic parameters, as well as the efficacy endpoints including time to alleviation of influenza symptoms, viral clearance rate, changes in viral load, etc.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female participants aged 2 to 18 years (≥2 years and <18 years).
- •For participants aged 5 to 18 years (excluding 18 years): body weight ≥20 kg; for participants aged 2 to 5 years (excluding 5 years): 10 kg≤body weight <20 kg.
- •Diagnosed with influenza virus infection based on the following criteria: • Positive rapid antigen test (RAT) result from a throat or nasal swab for influenza virus (rapid nucleic acid tests or other rapid molecular diagnostic tests are also acceptable); and
- •Fever at screening (axillary temperature ≥37.5°C). If antipyretics have been administered, axillary temperature should be ≥37.5°C at least 1 hour after administration, or fever (axillary temperature <37.5°C) that returns to ≥37.5°C more than 4 hours after antipyretic use; and
- •At least one moderate or severe respiratory symptom at screening, including cough and/or nasal congestion or runny nose.
- •Time interval between the onset of illness symptoms and enrollment is ≤48 hours.
- •Onset of illness: defined as the time of the first temperature increase (axillary temperature ≥37.5°C) or the time when at least one respiratory symptom related to influenza virus infection is first noticed by caregiver.
- •The participant's legal guardian agrees to the child's participation in the clinical study and signs the informed consent form (ICF). Participants aged ≥8 years must also voluntarily sign the ICF.
- •The investigator assesses that the participant and/or the caregiver can comply with the protocol requirements, follow-up visits, and complete all study procedures and evaluations, including diary card entries.
排除标准
- •Known allergy to the active ingredients or excipients of the investigational drug GP
- •Patients diagnosed with severe or critical influenza at screening: (1) Severe influenza cases were defined by the presence of one or more of the following conditions: a. Breathing difficulty and/or increased respiratory rate: >30 breaths/min for children >5 years old, >40 breaths/min for children aged 2-5 years; b. Consciousness alteration: slow response, somnolence, agitation, seizures, etc; c. Severe vomiting or diarrhea with moderate or severe dehydration; d. Pneumonia; e. Significant exacerbation of underlying diseases. (2) Critical influenza cases were defined by the presence of one or more of the following conditions: a. Respiratory failure; b. Acute necrotizing encephalopathy; c. Septic shock; d. Multiple organ dysfunction; e. Other severe clinical conditions requiring intensive care treatment.
- •Note: Refer to the "Expert Consensus on Diagnosis and Treatment of Influenza in Children (2020 Edition)" for the criteria of severe/critical influenza.
- •History of any gastrointestinal disease known to affect drug absorption (including but not limited to gastroesophageal reflux disease, chronic diarrhea, inflammatory bowel disease, intestinal tuberculosis, gastrinoma, short bowel syndrome, or post-gastrectomy conditions).
- •Suspected or confirmed bronchitis, pleural effusion, or interstitial pneumonia via clinical or radiological examination at screening.
- •Use of anti-influenza antiviral drugs within two weeks before screening (including neuraminidase inhibitors, hemagglutinin inhibitors, and M2 ion channel blockers such as oseltamivir phosphate, zanamivir, peramivir, favipiravir, arbidol, baloxavir, amantadine, or rimantadine, or other anti-influenza antiviral drugs approved by the NMPA).
- •Clinically relevant abnormal results in physical examination, 12-lead ECG, vital signs, hematology, clinical biochemistry, or urinalysis at screening, which in the investigator's judgment may pose a risk to the participant's safety, affect the study results, or impact the participant's ability to complete the study.
- •Acute respiratory tract infection, otitis media, or sinusitis within two weeks before screening.
- •Co-infection requiring systemic antibiotics or other systemic therapy at screening.
- •Known or suspected active primary or secondary immunodeficiency, including a history of HIV infection or other severe immunodeficiencies.
- •Known or suspected congenital abnormalities of the heart or lungs, or severe primary diseases affecting the cardiovascular, hepatic, renal, or hematopoietic systems, or evidence of active liver disease, including but not limited to jaundice or AST/ALT levels exceeding two times the upper limit of normal (ULN) at screening.
- •Positive serology for hepatitis B surface antigen or a history of hepatitis B infection at screening.
- •Note: Children and adolescents with a history of hepatitis B vaccination without a history of hepatitis B infection do not need to be screened for this criterion (assessed via medical history).
- •Obesity as determined by the investigator: For participants <6 years old: BMI >97th percentile for the corresponding age and gender group; For participants ≥6 years old: BMI ≥obesity threshold for the corresponding age and gender group.
- •Note: Refer to "WS/T 423-2022: Growth Standards for Children Under 7" or "WS/T586-2018: Screening for Overweight and Obesity in School-Aged Children and Adolescents."
- •History of mental illness, intellectual disability, substance abuse, or other adverse conditions (e.g., inability to read, understand, or write) that, in the investigator's judgment, may limit participation in the study.
- •Vaccination with an influenza vaccine within six months before screening or during the study period.
- •Note: Participants' influenza vaccination history should be carefully reviewed before study enrollment (assessed via medical history).
- •Participation in a clinical trial of any investigational drug or device for any indication within 30 days prior to screening.
- •Intolerance to skin puncture, fainting at the sight of blood or needles, or poor venous access for blood collection at screening.
- •Other conditions judged by the investigator to be unsuitable for participation in the study.
研究组 & 干预措施
GP681 powder for oral suspension 10mg/20mg/40mg
Experimental
All patients will receive a single oral dose of GP681 dry suspension dissolved in approximately 10 mL of warm water. The mixture will be stirred thoroughly before administration, and then the cup will be rinsed twice with an additional 10-20 mL of warm water (about 40°C) to ensure the full dose is taken.
The dosage of GP681 in patients 2-18 years of age is a single weight-based dose displayed in the following table.
Dosage Patients 40mg Aged 5-18years(exclusive)，weight≥40kg 20mg Aged 5-18years(exclusive)，20kg≤weight<40kg 40mg Aged 5-18years(exclusive)，20kg≤weight<40kg 10mg Aged 2-5years(exclusive)，10kg≤weight<20kg 20mg Aged 2-5years(exclusive)，10kg≤weight<20kg
干预措施: GP681 10mg/20mg/40mg (Drug)
结局指标
主要结局
Number of Participants with Adverse Events (AEs)
时间窗: up to Day 15
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.
次要结局
- Time to Alleviation of Symptoms (TTAS)(up to Day 15)
- Viral clearance rate on Day 2 and Day 5 (if applicable)(Days 2, 5)
- Proportion of patients with influenza viral RNA positivity (by Q-PCR) and measurable viral titers at each time point (Day 2 and Day 5, if applicable)(Days 2, 5)
- Area Under the Concentration (AUC) of virus RNA by RT-PCR and AUC of virus titer(Up to Day 5)
- Change From Baseline in Virus RNA (RT-PCR) at Each Time Point(Days 2, 5)
- Time to Resolution of Fever(Up to Day15)
- Time to return to normal activities of daily life(Up to Day15)
- Incidence of influenza-related complications(Up to Day15)
研究者
研究点 (1)
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