InfluenzaPhase 1NCT06643156
Study to Assess the Tolerability, Safety and Efficacy of GP681 Powder for Oral Suspension
A Phase 1 study testing GP681 10mg/20mg/40mg in people with Influenza, run by Jiangxi Qingfeng Pharmaceutical Co. Ltd. at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Influenza
- What is being tested?
- GP681 10mg/20mg/40mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 27 Sep 2024to 18 Jan 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- Known allergy to the active ingredients or excipients of the investigational drug GP681.
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
- Conditions
- Influenza
- Being tested
- GP681 10mg/20mg/40mg
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GP681 10mg/20mg/40mgDrug
0.5/1/2×20mg power for oral suspension taken orally
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: GP681 10mg/20mg/40mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events (AEs)
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.
Measured: up to Day 15
Secondary outcomes (8)
Time to Alleviation of Symptoms (TTAS)
Defined as the time from the treatment start to meeting both the following criteria (a and b), with all criteria maintained for at least 21.5 hours:
- Time from treatment initiation to the normalization of body temperature (axillary temperature ≤37.4°C).
Measured: up to Day 15
Viral clearance rate on Day 2 and Day 5 (if applicable)
Defined as the proportion of patients with viral titers below the quantifiable detection limit from the treatment start to Day 2 and Day 5 (if applicable)
Measured: 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)
The percentage of patients positive for virus RNA by RT-PCR.Virus titer was quantified from nasopharyngeal swabs by tissue culture methods.
Measured: Days 2, 5
Area Under the Concentration (AUC) of virus RNA by RT-PCR and AUC of virus titer
AUC of the viral load by RT-PCR and AUC of viral titer measured from baseline to Day 5
Measured: Up to Day 5
Change From Baseline in Virus RNA (RT-PCR) at Each Time Point
Nasopharyngeal swabs were obtained for viral quantitation.
Measured: Days 2, 5
Time to Resolution of Fever
Defined as the time to a score of 0 (none) or 1 (mild) for individual symptoms from the 16 items on the CARIFS scale, sustained for at least 21.5 hours.
Measured: Up to Day15
Time to return to normal activities of daily life
Defined as the time between the initiation of the study treatment and the return to normal activities of daily life.
Measured: Up to Day15
Incidence of influenza-related complications
Defined as the percentage of subjects in the analysis population who experience each influenza-related complication (hospitalization, death, sinusitis, bronchitis, otitis media, and pneumonia) as an adverse event after the initiation of the study treatment.
Measured: Up to Day15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start27 Sep 2024
- Primary completion18 Jan 2025
- Study completion18 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangxi Qingfeng Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06643156
- Sponsor's protocol ID
- GP681-S-202404
- Status last verified
- Mar 2025
- First submitted
- 9 Oct 2024
- Last updated
- 18 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06643156
- Acronym / sponsor ID
- GP681-S-202404
- Conditions
- Influenza
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Jiangxi Qingfeng Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Sep 2024 (actual)
- Primary completion
- 18 Jan 2025 (actual)
- Study completion
- 18 Jan 2025 (actual)
- First posted
- 16 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GP681 powder for oral suspension 10mg/20mg/40mg | Experimental | Drug: GP681 10mg/20mg/40mgAll 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 |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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
- 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.
Key exclusion criteria (21 listed)
- Known allergy to the active ingredients or excipients of the investigational drug GP681.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GP681 10mg/20mg/40mg0.5/1/2×20mg power for oral suspension taken orally | Drug | GP681 powder for oral suspension 10mg/20mg/40mg |
Primary outcome
Number of Participants with Adverse Events (AEs)
Time frame: 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.
8 secondary outcomes
Time to Alleviation of Symptoms (TTAS)
Time frame: up to Day 15
Viral clearance rate on Day 2 and Day 5 (if applicable)
Time frame: 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)
Time frame: Days 2, 5
Area Under the Concentration (AUC) of virus RNA by RT-PCR and AUC of virus titer
Time frame: Up to Day 5
Change From Baseline in Virus RNA (RT-PCR) at Each Time Point
Time frame: Days 2, 5
Time to Resolution of Fever
Time frame: Up to Day15
Time to return to normal activities of daily life
Time frame: Up to Day15
Incidence of influenza-related complications
Time frame: Up to Day15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GP681 10mg/20mg/40mg in people with Influenza, run by Jiangxi Qingfeng Pharmaceutical Co. Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events (AEs) (time frame: up to Day 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.