Influenza, Human study: GP681 vs GP681 Simulant
Official title Study of GP681 Tablets Compared With Placebo in Patients With Influenza at High Risk of Influenza Complications
ClinicalTrials.gov ID: NCT06573008
What this study is testing
What is GP681 40mg?
GP681 40mg is an investigational medicine, taken by mouth, being studied as a potential treatment for influenza, human.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see how well GP681 works, how safe it is, and how the drug moves through the body compared with a placebo.
- Who it's for
- People age 12 or older who have influenza and are considered at high risk for flu complications.
- What's involved
- Participants will receive one oral dose of GP681 or a matching placebo and will undergo safety checks and blood tests to measure drug levels.
- Time commitment
- A single dosing visit with a few follow‑up appointments over a short period to monitor safety and drug levels.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older. Healthy volunteers may be eligible.
You may be able to join if
- Male or female patients aged ≥12 years at the time of signing the informed consent form.
- Positive throat or nose swab by rapid influenza antigen test (RAT) (where rapid influenza virus nucleic acid test or other rapid molecular diagnostic...
- Fever (axillary temperature ≥37.3℃) in the predose examinations or \> 4 hours after dosing of antipyretics if they were taken;
- At least one of the following systemic symptoms and respiratory symptoms respectively associated with influenza are present with a severity of...
- Time of the first increase in body temperature (axillary temperature ≥37.3℃)
You likely can't join if
- History of allergic reactions attributed to GP681,Acetaminophen, bromohexine hydrochloride or any of the ingredients of its formulation.
- Known history of dysphagia or any gastrointestinal disease that affects drug absorption (including but not limited to chronic diarrhea, inflammatory...
- Screening patients who, in the opinion of the investigator, require hospitalization due to severe influenza virus infection;.
- Screening patients who, at the time of screening, are clinically diagnosed with bacterial or other viral infections requiring systemic antibacterial...
- Cancer patients who are currently receiving or have received chemotherapy or radiation therapy within the past year (excluding non-melanoma skin...
- Known HIV-infected patients;
See the full eligibility criteria
Who can join
- Male or female patients aged ≥12 years at the time of signing the informed consent form.
- Positive throat or nose swab by rapid influenza antigen test (RAT) (where rapid influenza virus nucleic acid test or other rapid molecular diagnostic methods are also acceptable);
- Fever (axillary temperature ≥37.3℃) in the predose examinations or \> 4 hours after dosing of antipyretics if they were taken;
- 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...
- Time of the first increase in body temperature (axillary temperature ≥37.3℃)
- Time when the patient experiences at least 1 new general or respiratory symptom related to influenza
- Asthma or chronic lung diseases [such as chronic obstructive pulmonary disease (COPD), cystic fibrosis, chronic bronchitis, bronchiectasis, emphysema, chronic interstitial pneumonia, etc.];
- Endocrine disorders (including diabetes);
- Residents of long-term care institutions (such as nursing homes);
- Immune system impairment (including patients receiving chronic systemic corticosteroid treatment of ≤20mg/d prednisone or an equivalent dose);
- Neurological and neurodevelopmental disorders (including brain, spinal cord, peripheral nerve and muscle diseases, such as cerebral palsy, epilepsy (episodic disorders), stroke, muscular dystrophy or spinal cord injury);
- Heart diseases (such as congenital heart disease, congestive heart failure, or coronary artery disease), but not including hypertension without any other cardiac-related symptoms;
- Patients aged ≥65 years;
- Blood system diseases (such as sickle cell disease);
- Metabolic system diseases (such as hereditary metabolic diseases and mitochondrial diseases);
- Liver diseases (such as chronic hepatitis B, chronic hepatitis C, non-alcoholic steatohepatitis);
- Kidney diseases (estimated glomerular filtration rate eGFR ≥ 30 mL/min/1.73m2 by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula);
- Obese patients (BMI ≥ 30 kg/m2);
- Female patients within 2 weeks postpartum and not breastfeeding.
- people of child-bearing potential who agree to use a highly effective method of contraception for 1 month after drug withdrawal.
- people 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...
What rules you out
- History of allergic reactions attributed to GP681,Acetaminophen, bromohexine hydrochloride or any of the ingredients of its formulation.
- Known history of dysphagia or any gastrointestinal disease that affects drug absorption (including but not limited to chronic diarrhea, inflammatory bowel disease, tuberculosis of the intestines, gastrinoma, short bowel...
- Screening patients who, in the opinion of the investigator, require hospitalization due to severe influenza virus infection;.
- Screening patients who, at the time of screening, are clinically diagnosed with bacterial or other viral infections requiring systemic antibacterial or antiviral treatment;
- Cancer patients who are currently receiving or have received chemotherapy or radiation therapy within the past year (excluding non-melanoma skin cancer and thyroid cancer)
- Known HIV-infected patients;
- Organ or bone marrow transplant recipients;
- Patients who are currently receiving \>20mg/d of prednisone or equivalent chronic systemic corticosteroid therapy;
- Patients who have used anti-influenza virus drugs (including neuraminidase inhibitors, hemagglutinin inhibitors, and M2 ion channel blockers, such as oseltamivir, zanamivir, palivizumab, favipiravir, abidol...
- Exclusion of participants who have received clinical research or screening within the past 30 days for any indication with a trial drug or device, or who have received clinical research for a monoclonal antibody drug...
- Known to have had a previous history of severe liver function impairment such as cirrhosis with ascites, hepatic encephalopathy, or a history of upper gastrointestinal bleeding;
- Estimated glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula \<30mL/min/1.73m2 at the time of screening;
- Individuals with a history of alcohol abuse or substance abuse (more than 14 units of alcohol per week, 1 unit of alcohol = 360 mL of beer or 45 mL of spirits with an alcohol content of 40% or 150 mL of wine with an...
- Adult reproductive-age females who are pregnant or breastfeeding or who have a positive pregnancy test.
- Patients who, in the opinion of the Investigator, may not be qualified or suitable for the study.
The study team makes the final eligibility decision.
Where it is enrolling
- Chizhou, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Chizhou, China. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.