Influenza Type APhase 3NCT06507813
Safety and Efficacy of ADC189 in Children 2-11 Years Old With Influenza
A Phase 3 study testing ADC189 tablets, Baloxavir Marboxil tablets and ADC189 granules in people with Influenza Type A and Influenza Type B, run by Jiaxing AnDiCon Biotech Co.,Ltd at 1 site in China.
Trial summary
Currently, there is only one treatment which only need one single oral dose for influenza in children five years above (Baloxavir marboxil) in China. This study will test a medicine for influenza in children younger than 5 year of age to see if it is safe and effective. Read more about this study
- Who is it for?
- Ages 2 to 11 years
- Conditions the study is for
- Influenza Type A, Influenza Type B
- What is being tested?
- ADC189 tablets, Baloxavir Marboxil tablets and ADC189 granules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 190 participants
- Where
- 1 siteChina
- Study dates
- 19 Aug 2024to 15 Apr 2025
- Phase
- Phase 3
- 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 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1. Patients aged 2 to 11 years at screening, both sex;
- 2. Patients were diagnosed with Influenza A Vairus Infection/Influenza B Virus Infection.
- 3. Parents willing and able to comply with study requirements, under the judgment of investigators .
- 4. Onset of symptoms no more than 48 hours before presentation for screening.
Who cannot join
- 1. Patients with severe influenza.
- 2. Pregnant or breast-feeding females
- 3. Patients with acute respiratory infection, tympanitis, sinusitis, or acute asthma attack within 2 weeks before screening.
- 4. Presence of a chronic disease or illness that may indicate increased risk for influenza-related complications.
- 5. Other antiviral therapy is required during screening.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Children's Hospital,Capital Medical University
Beijing, Beijing Municipality
About this study
Official title: A Phase III, Multicenter, Randomized, Double-blind, Controlled Study to Evaluate Pharmacokinetics, Safety and Efficacy of ADC189 Tablets/Granules in Children 2-11 Years Old With Influenza
Currently, there is only one treatment which only need one single oral dose for influenza in children five years above (Baloxavir marboxil) in China. This study will test a medicine for influenza in children younger than 5 year of age to see if it is safe and effective.
This is a multicenter, randomized, double-blind, controlled Phase III clinical study.
The study evaluates the pharmacokinetics, safety and efficacy of ADC189 tablets/granules following a single oral dose in children aged 2 to 11 years with influenza.
- Conditions
- Influenza Type A, Influenza Type B
- Being tested
- ADC189 tablets, Baloxavir Marboxil tablets, Placebo of ADC189 tablets, Placebo of Baloxavir Marboxil tablets, ADC189 granules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADC189 tabletsDrug
Patients weigh between 20 to 80 kilograms, given 45 mg ADC189 tablets once; patients weigh over 80 kilograms, given 90 mg ADC189 tablets once.
Baloxavir Marboxil tabletsDrug
Patients weigh between 20 to 80 kilograms, given 40 mg Baloxavir marboxil tablets once. Patients weigh over 80 kilograms, given 80 mg Baloxavir marboxil tablets once.
Placebo of ADC189 tabletsDrug
Patients weigh between 20 to 80 kilograms, given 1 tablet of placebo once; patients weigh over 80 kilograms, given 2 tablets of placebo once.
Placebo of Baloxavir Marboxil tabletsDrug
Patients weigh between 20 to 80 kilograms, given 2 tablets of placebo once; patients weigh over 80 kilograms, given 4 tablets of placebo once.
ADC189 granulesDrug
For patient 5-11 years old, patients weigh between 20 to 80 kilograms, given 45 mg ADC189 granules once; patients weigh over 80 kilograms, given 90 mg ADC189 granules once.
For patient 2-4 years old, patients <10kg, given 15mg ADC189 granules once. 10kg ~ <15kg, given 25mg ADC189 granules once. 15kg ~<20 kg, given 35mg ADC189 granules once. 20kg ~ <80kg, given 45mg ADC189 granules once.
Placebo of ADC189 granulesDrug
Placebo. Given once only.
Placebo of Oseltamivir granulesDrug
For patients 2-4 years old. Placebo. Given 10 times (5 days, BID).
Oseltamivir granulesDrug
For patients 2-4 years old. Patients <15kg, given 30mg×10 times (5 days, BID) Oseltamivir granules. 15kg ~ <23kg, given 45mg×10 times (5 days, BID) Oseltamivir granules. 23kg ~ <40kg, given 60mg×10 times (5 days, BID) Oseltamivir granules. ≥40kg, given 75mg×10 times (5 days, BID) Oseltamivir granules.
| Study group | Role | What they receive |
|---|---|---|
| ADC189 tablets Group (Part 1) | Experimental | Around 30 patients, 6-11 years old. Receives: Drug: ADC189 tablets; Drug: Placebo of Baloxavir Marboxil tablets |
| Baloxavir marboxil tablets Group (Part 1) | Active comparator | Around 15 patients, 6-11 years old. Receives: Drug: Baloxavir Marboxil tablets; Drug: Placebo of ADC189 tablets |
| ADC189 granules Group (Part 2A) | Experimental | Around 60 patients, 5-11 years old. Receives: Drug: Placebo of Baloxavir Marboxil tablets; Drug: ADC189 granules |
| Baloxavir marboxil tablets (Part 2A) | Active comparator | Around 30 patients, 5-11 years old. Receives: Drug: Baloxavir Marboxil tablets; Drug: Placebo of ADC189 granules |
| ADC189 granules (Part 2B) | Experimental | Around 20 patients, 2-4 years old. Receives: Drug: ADC189 granules; Drug: Placebo of Oseltamivir granules |
| Oseltamivir granules (Part 2B) | Active comparator | Around 10 patients, 2-4 years old. Receives: Drug: Placebo of ADC189 granules; Drug: Oseltamivir granules |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety of study drug, Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. A SAE is any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/ incapacity, is a congenital anomaly/ birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above.
Measured: From Day 1 up to 15 days
Secondary outcomes (2)
Plasma Concentrations of ADC189 and ADC189-I07
ADC189-I07 is an active metabolite of ADC189. Four plasma samples were collected in 4 time points from each patient. This data is collected for Pop PK analysis.
Measured: From Day 1 up to 14 days, 4 time points.
Time to Resolution of Influenza Symptoms
Subjects or parents or caregivers were asked to provide an assessment of age-appropriate influenza symptoms on a CARIFS Questionare.
Measured: From Day 1 up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start19 Aug 2024
- Primary completion27 Jan 2025
- Study completion15 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza Type AStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiaxing AnDiCon Biotech Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06507813
- Sponsor's protocol ID
- ADC189GR-20230808
- Status last verified
- Sep 2025
- First submitted
- 12 Jul 2024
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- 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 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multicenter, Randomized, Double-blind, Controlled Study to Evaluate Pharmacokinetics, Safety and Efficacy of ADC189 Tablets/Granules in Children 2-11 Years Old With Influenza
- ClinicalTrials.gov ID
- NCT06507813
- Acronym / sponsor ID
- ADC189GR-20230808
- Conditions
- Influenza Type A, Influenza Type B
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Jiaxing AnDiCon Biotech Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 19 Aug 2024 (actual)
- Primary completion
- 27 Jan 2025 (actual)
- Study completion
- 15 Apr 2025 (actual)
- First posted
- 18 Jul 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.
Currently, there is only one treatment which only need one single oral dose for influenza in children five years above (Baloxavir marboxil) in China. This study will test a medicine for influenza in children younger than 5 year of age to see if it is safe and effective.
This is a multicenter, randomized, double-blind, controlled Phase III clinical study.
The study evaluates the pharmacokinetics, safety and efficacy of ADC189 tablets/granules following a single oral dose in children aged 2 to 11 years with influenza.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| ADC189 tablets Group (Part 1) | Experimental | Drug: ADC189 tablets, Drug: Placebo of Baloxavir Marboxil tabletsAround 30 patients, 6-11 years old. |
| Baloxavir marboxil tablets Group (Part 1) | Active comparator | Drug: Baloxavir Marboxil tablets, Drug: Placebo of ADC189 tabletsAround 15 patients, 6-11 years old. |
| ADC189 granules Group (Part 2A) | Experimental | Drug: Placebo of Baloxavir Marboxil tablets, Drug: ADC189 granulesAround 60 patients, 5-11 years old. |
| Baloxavir marboxil tablets (Part 2A) | Active comparator | Drug: Baloxavir Marboxil tablets, Drug: Placebo of ADC189 granulesAround 30 patients, 5-11 years old. |
| ADC189 granules (Part 2B) | Experimental | Drug: ADC189 granules, Drug: Placebo of Oseltamivir granulesAround 20 patients, 2-4 years old. |
| Oseltamivir granules (Part 2B) | Active comparator | Drug: Placebo of ADC189 granules, Drug: Oseltamivir granulesAround 10 patients, 2-4 years old. |
Who may qualify
- Ages
- 2 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 1. Patients aged 2 to 11 years at screening, both sex;
- 2. Patients were diagnosed with Influenza A Vairus Infection/Influenza B Virus Infection.
- 3. Parents willing and able to comply with study requirements, under the judgment of investigators .
- 4. Onset of symptoms no more than 48 hours before presentation for screening.
Key exclusion criteria (5 listed)
- 1. Patients with severe influenza.
- 2. Pregnant or breast-feeding females
- 3. Patients with acute respiratory infection, tympanitis, sinusitis, or acute asthma attack within 2 weeks before screening.
- 4. Presence of a chronic disease or illness that may indicate increased risk for influenza-related complications.
- 5. Other antiviral therapy is required during 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 |
|---|---|---|
| ADC189 tabletsPatients weigh between 20 to 80 kilograms, given 45 mg ADC189 tablets once; patients weigh over 80 kilograms, given 90 mg ADC189 tablets once. | Drug | ADC189 tablets Group (Part 1) |
| Baloxavir Marboxil tabletsPatients weigh between 20 to 80 kilograms, given 40 mg Baloxavir marboxil tablets once. Patients weigh over 80 kilograms, given 80 mg Baloxavir marboxil tablets once. | Drug | Baloxavir marboxil tablets (Part 2A), Baloxavir marboxil tablets Group (Part 1) |
| Placebo of ADC189 tabletsPatients weigh between 20 to 80 kilograms, given 1 tablet of placebo once; patients weigh over 80 kilograms, given 2 tablets of placebo once. | Drug | Baloxavir marboxil tablets Group (Part 1) |
| Placebo of Baloxavir Marboxil tabletsPatients weigh between 20 to 80 kilograms, given 2 tablets of placebo once; patients weigh over 80 kilograms, given 4 tablets of placebo once. | Drug | ADC189 granules Group (Part 2A), ADC189 tablets Group (Part 1) |
| ADC189 granulesFor patient 5-11 years old, patients weigh between 20 to 80 kilograms, given 45 mg ADC189 granules once; patients weigh over 80 kilograms, given 90 mg ADC189 granules once. For patient 2-4 years old, patients <10kg, given 15mg ADC189 granules once. 10kg ~ <15kg, given 25mg ADC189 granules once. 15kg ~<20 kg, given 35mg ADC189 granules once. 20kg ~ <80kg, given 45mg ADC189 granules once. | Drug | ADC189 granules (Part 2B), ADC189 granules Group (Part 2A) |
| Placebo of ADC189 granulesPlacebo. Given once only. | Drug | Baloxavir marboxil tablets (Part 2A), Oseltamivir granules (Part 2B) |
| Placebo of Oseltamivir granulesFor patients 2-4 years old. Placebo. Given 10 times (5 days, BID). | Drug | ADC189 granules (Part 2B) |
| Oseltamivir granulesFor patients 2-4 years old. Patients <15kg, given 30mg×10 times (5 days, BID) Oseltamivir granules. 15kg ~ <23kg, given 45mg×10 times (5 days, BID) Oseltamivir granules. 23kg ~ <40kg, given 60mg×10 times (5 days, BID) Oseltamivir granules. ≥40kg, given 75mg×10 times (5 days, BID) Oseltamivir granules. | Drug | Oseltamivir granules (Part 2B) |
Primary outcome
The safety of study drug, Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From Day 1 up to 15 days
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. A SAE is any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/ incapacity, is a congenital anomaly/ birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above.
2 secondary outcomes
Plasma Concentrations of ADC189 and ADC189-I07
Time frame: From Day 1 up to 14 days, 4 time points.
Time to Resolution of Influenza Symptoms
Time frame: From Day 1 up to 14 days
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 23 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Influenza Type A
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
Active, not recruitingObservational study
A Study to Look at the Health Outcomes of Patients With COVID-19 and Influenza
COVID-19, Coronavirus Disease 2019
Not yet recruitingPhase 2/3
Phase 2/3 Clinical Trial to Evaluate the Immunogenicity and Safety of GC3114B in Adults Aged 65 Years or Older
Influenza A, Influenza B, Influenza Vaccination
Not yet recruiting
Usability and Clinical Validation of the Flu A/B/COVID-19 + RSV Multiplex Rapid Test
SARS-CoV-2 Infection, Influenza A
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 3 study testing ADC189 tablets, Baloxavir Marboxil tablets and ADC189 granules in people with Influenza Type A and Influenza Type B, run by Jiaxing AnDiCon Biotech 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 4 inclusion and 5 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 23 Sep 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The safety of study drug, Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: From Day 1 up to 15 days). 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 23 Sep 2025.