Safety IssuesPhase 2/3ADCNCT06342921
ADC189 Tablets on Influenza A Virus Infection/Influenza B Virus Infection
A Phase 2/3 study testing 15 mg ADC189 and 45 mg ADC189 in people with Safety Issues and Effect of Drug, run by Jiaxing AnDiCon Biotech Co.,Ltd at 1 site in China.
Trial summary
The goal of this Phase II/III study is to investigate the safty and efficacy of ADC189 tablets in adolescents and adults with influenza A virus infection/influenza B virus infection. Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Safety Issues, Effect of Drug
- What is being tested?
- 15 mg ADC189 and 45 mg ADC189
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 749 participants
- Where
- 1 siteChina
- Study dates
- 7 Dec 2022to 22 Jan 2024
- Phase
- Phase 2/3
- 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 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients aged 18 to 65 years (including the cut-off point, Phase II) or 12 to 65 years (including the cut-off point, Phase III) with a body weight ≥ 20 kg, both sex;
- Patients were diagnosed with Influenza A Virus Infection/Influenza B Virus Infection according to the following criteria: nasopharyngeal swab or oropharyngeal swab was positive under influenza rapid antigen test (RAT) (rapid influenza virus nucleic acid test or other rapid molecular diagnostic methods are also acceptable); and fever (ear temperature ≥ 37.3°C or axillary temperature ≥ 37.2°C), if taking antipyretics, ear temperature ≥ 37.3°C or axillary temperature ≥ 37.2°C after 4 hours taking antipyretics; at least one of the following symptoms are moderate or above (influenza symptom severity score ≥ 2) related to influenza: systemic symptoms: headache, fever or chills, muscle or joint aches, fatigue; respiratory symptoms: cough, sore throat, nasal congestion;
- The time interval from the onset time of influenza to screening start ≤ 48 hours. Definition of influenza onset: the fever (ear temperature ≥37.3°C or axillary temperature ≥37.2°C or oral temperature ≥37.7°C) (ear temperature, axillary temperature and oral temperature measurements are acceptable), or the onset of any systemic symptoms or respiratory symptoms related to influenza;
- Fertile subjects (including their partners) agree to take effective contraceptive methods throughout the study period and 3 months after study.
- Voluntary participation in this clinical study and signing of the informed consent.
Who cannot join
- Patients with known allergies to the test preparation, any of its components or related preparations (or severe allergic constitution), and who are judged by the investigator to have a safety risk for enter the trial;
- Patients diagnosed as severe/critical flu at screening, as defined below:
- Severe cases are defined as those meeting one of the following conditions:
- High fever over 3 days, accompanied by severe cough, expectoration, bloody sputum, or chest pain; rapid breathing, dyspnea, and cyanosis of the lips; mental changes such as slow response, drowsiness, restlessness, or convulsions; severe vomiting, diarrhea, and dehydration; complicated with pneumonia; significant exacerbation of the original underlying disease;
- Critical cases are defined as those meeting one of the following conditions:
- Respiratory failure; acute necrotizing encephalopathy; shock; multiple organ dysfunction;
Show all 16Show fewer
- High-risk population in severe cases are defined as those meeting any of the following conditions, and who are judged by the investigator to have a safety risk in the trial:
- Patients with severe or poorly controlled underlying diseases, such as chronic respiratory diseases, liver diseases, chronic kidney diseases, severe hematological diseases, chronic congestive heart failure [New York Heart Association (NYHA) cardiac function classification III-IV], nervous system and neuromuscular diseases, metabolic diseases, etc.; Subjects with clinically significant abnormalities in the corrected QT interval (QTc> 450ms for males or QTc> 470ms for females) on electrocardiogram (QTcF calculated according to the Fridericia formula); Subjects with immunodeficiency, such as malignant tumor, organ or bone marrow transplantation, HIV infection, or taking immunosuppressants in the past 3 months; Subjects with other diseases requiring treatment with aspirin or salicylate drugs; Subjects with obesity [body mass index (BMI) greater than 30 kg/m2].
- Subjects with a 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, post-subtotal gastrectomy, etc.);
- Subjects who had used anti-influenza virus drugs (oseltamivir, zanamivir, peramivir, favipiravir, arbidol, baloxavir, amantadine or rimantadine, etc.) within 2 weeks before screening or had received influenza vaccine within 6 months before screening;
- Subjects with acute respiratory tract infection, otitis media, sinusitis or other infectious diseases such as bronchitis, pneumonia, tuberculosis or other infectious diseases within 2 weeks before screening;
- Subjects with other bacterial or viral infections at the time of screening and need systemic antibacterial or antiviral treatment, or subjects with blood routine test: white blood cell count (WBC) > 10.0×109/L at the time of screening;
- Pregnant or lactating women or positive pregnancy test. Pregnancy test is not required for women who have stopped menstruation for more than 2 years, confirmed postmenopausal women or women who have undergone hysterectomy, bilateral oophorectomy or tubal ligation surgery;
- Suspected or confirmed history of alcohol or drug abuse;
- Those who have participated in other drug clinical trials within 3 months before taking the drug;
- Those who are not suitable for participation in the study in the judgment of the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II/III Study of the Safety and Efficacy of ADC189 Tablets in the Treatment of Influenza A Virus Infection/Influenza B Virus Infection in Adolescents and Adults
The goal of this Phase II/III study is to investigate the safty and efficacy of ADC189 tablets in adolescents and adults with influenza A virus infection/influenza B virus infection.
The main aim to answer:
Read more
- Phase II study is to evaluate the efficacy of ADC189 tablets in the treatment of adult influenza subjects and determine the optimal therapeutic dose by analyzing the time of virus titer turning to negative. All the results will be used to design the Phase III study.
- Phase III study is to evaluate the efficacy of ADC189 tablets by analyzing the duration of remission of all influenza symptoms in adolescents and adults subjects with influenza.
Participants will be taken ADC189 teblets/Placebo once, and be observed by 22 days.
Phase II study has 3 groups: 15 mg ADC189; 45 mg ADC189; and Placebo; Phase III study has 2 groups: 45 mg ADC189; and Placebo.
- Conditions
- Safety Issues, Effect of Drug
- Being tested
- 15 mg ADC189, 45 mg ADC189, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
15 mg ADC189Drug
Use only once during the whole study.
45 mg ADC189Drug
Use only once during the whole study.
PlaceboDrug
Use only once during the whole study.
| Study group | Role | What they receive |
|---|---|---|
| 15 mg | Experimental | 15 mg of ADC189 tablets Once during the whole study. Receives: Drug: 15 mg ADC189 |
| 45 mg | Experimental | 45 mg of ADC189 tablets Once during the whole study. Receives: Drug: 45 mg ADC189 |
| Placebo | Placebo comparator | Once during the whole study. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
the severity of influenza
All subjects recorded 7 symptoms associated with influenza (cough, sore throat, headache, nasal congestion, fever or chills, muscle or joint pain, and fatigue) on a 4-point scale (0 points, none; 1 point, mild; 2 points, moderate; 3 points, severe) in a self-assessment on Dairy Card.
Measured: 22 days
the safety of study drug
Collect all the Adverse Events during the whole study.
Measured: 22 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start7 Dec 2022
- Primary completion8 Oct 2023
- Study completion22 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Safety IssuesStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 749 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
- NCT06342921
- Sponsor's protocol ID
- ADC189-2022-01
- Acronym
- ADC
- Status last verified
- Mar 2024
- First submitted
- 12 Mar 2024
- Last updated
- 21 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhao J, Sheng G, Lyu Y, Sun Y, Wang S, Chen X, Ye F, Chen L, Xu X, Wang H, Wu B, Peng C, Deng M, Qu L, Jiang X, Hu J, Feng Y, Li Y, Peng J, Li W, Shao L, Gao F, Tian D, Tan J, Zheng H, Chen M, Wu H, Zhu X, Zhou M, Qu J. Oral ADC189 for adults and adolescents with uncomplicated influenza. J Infect. 2025 Apr;90(4):106472. doi: 10.1016/j.jinf.2025.106472. Epub 2025 Mar 13.
PubMed 40089214
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II/III Study of the Safety and Efficacy of ADC189 Tablets in the Treatment of Influenza A Virus Infection/Influenza B Virus Infection in Adolescents and Adults
- ClinicalTrials.gov ID
- NCT06342921
- Acronym / sponsor ID
- ADC / ADC189-2022-01
- Conditions
- Safety Issues, Effect of Drug
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 749 participants (actual)
- Lead sponsor
- Jiaxing AnDiCon Biotech Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 7 Dec 2022 (actual)
- Primary completion
- 8 Oct 2023 (actual)
- Study completion
- 22 Jan 2024 (actual)
- First posted
- 2 Apr 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.
The goal of this Phase II/III study is to investigate the safty and efficacy of ADC189 tablets in adolescents and adults with influenza A virus infection/influenza B virus infection.
The main aim to answer:
- Phase II study is to evaluate the efficacy of ADC189 tablets in the treatment of adult influenza subjects and determine the optimal therapeutic dose by analyzing the time of virus titer turning to negative. All the results will be used to design the Phase III study.
- Phase III study is to evaluate the efficacy of ADC189 tablets by analyzing the duration of remission of all influenza symptoms in adolescents and adults subjects with influenza.
Participants will be taken ADC189 teblets/Placebo once, and be observed by 22 days.
Phase II study has 3 groups: 15 mg ADC189; 45 mg ADC189; and Placebo; Phase III study has 2 groups: 45 mg ADC189; and Placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 15 mg | Experimental | Drug: 15 mg ADC18915 mg of ADC189 tablets Once during the whole study. |
| 45 mg | Experimental | Drug: 45 mg ADC18945 mg of ADC189 tablets Once during the whole study. |
| Placebo | Placebo comparator | Drug: PlaceboOnce during the whole study. |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 18 to 65 years (including the cut-off point, Phase II) or 12 to 65 years (including the cut-off point, Phase III) with a body weight ≥ 20 kg, both sex;
- Patients were diagnosed with Influenza A Virus Infection/Influenza B Virus Infection according to the following criteria: nasopharyngeal swab or oropharyngeal swab was positive under influenza rapid antigen test (RAT) (rapid influenza virus nucleic acid test or other rapid molecular diagnostic methods are also acceptable); and fever (ear temperature ≥ 37.3°C or axillary temperature ≥ 37.2°C), if taking antipyretics, ear temperature ≥ 37.3°C or axillary temperature ≥ 37.2°C after 4 hours taking antipyretics; at least one of the following symptoms are moderate or above (influenza symptom severity score ≥ 2) related to influenza: systemic symptoms: headache, fever or chills, muscle or joint aches, fatigue; respiratory symptoms: cough, sore throat, nasal congestion;
- The time interval from the onset time of influenza to screening start ≤ 48 hours. Definition of influenza onset: the fever (ear temperature ≥37.3°C or axillary temperature ≥37.2°C or oral temperature ≥37.7°C) (ear temperature, axillary temperature and oral temperature measurements are acceptable), or the onset of any systemic symptoms or respiratory symptoms related to influenza;
- Fertile subjects (including their partners) agree to take effective contraceptive methods throughout the study period and 3 months after study.
- Voluntary participation in this clinical study and signing of the informed consent.
Key exclusion criteria (16 listed)
- Patients with known allergies to the test preparation, any of its components or related preparations (or severe allergic constitution), and who are judged by the investigator to have a safety risk for enter the trial;
- Patients diagnosed as severe/critical flu at screening, as defined below:
- High fever over 3 days, accompanied by severe cough, expectoration, bloody sputum, or chest pain; rapid breathing, dyspnea, and cyanosis of the lips; mental changes such as slow response, drowsiness, restlessness, or convulsions; severe vomiting, diarrhea, and dehydration; complicated with pneumonia; significant exacerbation of the original underlying disease;
- Respiratory failure; acute necrotizing encephalopathy; shock; multiple organ dysfunction;
- High-risk population in severe cases are defined as those meeting any of the following conditions, and who are judged by the investigator to have a safety risk in the trial:
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 |
|---|---|---|
| 15 mg ADC189Use only once during the whole study. | Drug | 15 mg |
| 45 mg ADC189Use only once during the whole study. | Drug | 45 mg |
| PlaceboUse only once during the whole study. | Drug | Placebo |
Primary outcome
the severity of influenza
Time frame: 22 days
All subjects recorded 7 symptoms associated with influenza (cough, sore throat, headache, nasal congestion, fever or chills, muscle or joint pain, and fatigue) on a 4-point scale (0 points, none; 1 point, mild; 2 points, moderate; 3 points, severe) in a self-assessment on Dairy Card.
the safety of study drug
Time frame: 22 days
Collect all the Adverse Events during the whole study.
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 21 Jan 2025.
- Derived from this study: PubMed 40089214Zhao J, Sheng G, Lyu Y, Sun Y, Wang S, Chen X, Ye F, Chen L, Xu X, Wang H, Wu B, Peng C, Deng M, Qu L, Jiang X, Hu J, Feng Y, Li Y, Peng J, Li W, Shao L, Gao F, Tian D, Tan J, Zheng H, Chen M, Wu H, Zhu X, Zhou M, Qu J. Oral ADC189 for adults and adolescents with uncomplicated influenza. J Infect. 2025 Apr;90(4):106472. doi: 10.1016/j.jinf.2025.106472. Epub 2025 Mar 13.
- 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 2/3 study testing 15 mg ADC189 and 45 mg ADC189 in people with Safety Issues and Effect of Drug, 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 5 inclusion and 16 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 21 Jan 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 severity of influenza (time frame: 22 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06342921, which also lists 1 linked publication.
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 21 Jan 2025.