Influenza, HumanPhase 2/3NCT07893847
Evaluation of the Efficacy and Safety of 102D-6 in the Treatment of Acute Uncomplicated Influenza
A Phase 2/3 study testing 20 mg 102D-6 dry suspension and 40 mg 102D-6 dry suspension in people with Influenza, Human, run by Capital Medical University at 1 site in China.
Trial summary
The goal of this Phase II/III study is to investigate the safty and efficacy of 102D-6 in adolescents and adults with influenza. The main aim to answer: 1. Phase II study is to evaluate the efficacy of 102D-6 in the treatment of adult influenza subjects and determine the optimal therapeutic dose by analyzing the time… Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Influenza, Human
- What is being tested?
- 20 mg 102D-6 dry suspension and 40 mg 102D-6 dry suspension
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 570 participants
- Where
- 1 siteChina
- Study dates
- 21 Oct 2026to 30 Mar 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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
- Aged 18 to 65 years (including cut-off value), male or female;
- Patients in the screening period met the following criteria:
- Rapid influenza diagnostic test (RIDT) or polymerase chain reaction (PCR) test positive;
- Pyrexial (axillary temperature ≥ 37.3 °C). If antipyretic drugs (including Chinese patent medicines) are taken, the axillary temperature should be ≥ 37.3 °C after administration(more than 4 hours);
- At least one Influenza viral infections-related General symptoms (Headache, Pyrexial or chills, muscle or Soreness of joint, Lassitude) score ≥ 2 points;
- At least one Influenza viral infections-related respiratory symptom (Coughing, Pharyngalgia, Nasal obstruction) score ≥ 2 points;
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- The first occurrence of influenza symptoms ≤ 48 hours from the time of patient randomization.
- Aged 12 to 65 years (including cut-off value), male or female;
- Patients in the screening period met the following criteria:
- Rapid influenza diagnostic test (RIDT) or polymerase chain reaction (PCR) test positive;
- Fever ≥ 37.3 °C(axillary temperature) at Screening. If antipyretic drugs (including Chinese patent medicines) are taken, the axillary temperature should be ≥ 37.3 °C after administration(more than 4 hours);
- At least one Influenza viral infections-related General symptoms (Headache, Pyrexial or chills, muscle or Soreness of joint, Lassitude) score ≥ 2 points;
- At least one Influenza viral infections-related respiratory symptom (Coughing, Pharyngalgia, Nasal obstruction) score ≥ 2 points;
- The first occurrence of influenza symptoms ≤ 48 hours from the time of patient randomization.
- Aged 18 to 65 years (including cut-off value), male or female;
- Patients in the screening period met the following criteria:
- Rapid influenza diagnostic test (RIDT) or polymerase chain reaction (PCR) test positive;
- Pyrexial (axillary temperature ≥ 37.3 °C). If antipyretic drugs (including Chinese patent medicines) are taken, the axillary temperature should be ≥ 37.3 °C after administration(more than 4 hours);
- At least one Influenza viral infections-related General symptoms (Headache, Pyrexial or chills, muscle or Soreness of joint, Lassitude) score ≥ 2 points;
- At least one Influenza viral infections-related respiratory symptom (Coughing, Pharyngalgia, Nasal obstruction) score ≥ 2 points;
- The first occurrence of influenza symptoms ≤ 48 hours from the time of patient randomization.
- 1. Aged 12 to 65 years (including cut-off value), male or female; 2.Patients in the screening period met the following criteria:
- Rapid influenza diagnostic test (RIDT) or polymerase chain reaction (PCR) test positive;
- Fever ≥ 37.3 °C(axillary temperature) at Screening. If antipyretic drugs (including Chinese patent medicines) are taken, the axillary temperature should be ≥ 37.3 °C after administration(more than 4 hours);
- At least one Influenza viral infections-related General symptoms (Headache, Pyrexial or chills, muscle or Soreness of joint, Lassitude) score ≥ 2 points;
- At least one Influenza viral infections-related respiratory symptom (Coughing, Pharyngalgia, Nasal obstruction) score ≥ 2 points; 3.The first occurrence of influenza symptoms ≤ 48 hours from the time of patient randomization.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Yeming Wang, PhD, 18801663558, wyymm_love@163.com
About this study
Official title: A Randomized, Double-blind, Multicenter, Phase II/III Study to Evaluate the Efficacy and Safety of 102D-6 in the Treatment of Uncomplicated Influenza.
The goal of this Phase II/III study is to investigate the safty and efficacy of 102D-6 in adolescents and adults with influenza.
The main aim to answer:
- Phase II study is to evaluate the efficacy of 102D-6 in the treatment of adult influenza subjects and determine the optimal therapeutic dose by analyzing the time of virus titer turning to negative. The results will be used to design the Phase III study.
- Phase III study is to evaluate the efficacy of 102D-6 by analyzing the duration of remission of all influenza symptoms in adolescents and adults subjects with influenza.
Participants will be taken 102D-6/Placebo once, and be observed by 15 days.
Read the detailed description
Phase II Screening and Treatment Period: screening Investigation and Flu symptoms assessments, virological testing will be performed. Successfully screened participants will be stratified and randomized according to Weight (≥ 20 kg and < 80 kg, ≥ 80 kg) in a 1: 1: 1 ratio to low dose, high dose, or PLACEBO, with a single oral dose of low dose 102D-6 dry suspension, high dose 102D-6 dry suspension, or placebo. Participants should complete baseline assessments of Body temperature, Flu symptoms, and health status prior to dosing.
After completion of dosing, the subject entered the safety follow-up period. On the day of dosing (D1) and on Days 2 to 14 of the follow-up period (D2 to D14), participants were required to receive the corresponding Investigation on the specified visit dates, and Body temperature, Flu symptoms, and health status were recorded daily.
On Day 15, participants were required to visit the study site for an end-of-observation visit (EOS). If a participant withdraws from the study early, he/she will be required to attend the study center for an early termination visit within 3 days of the decision to withdraw from the study.
Phase III Screening and Treatment Period: screening Investigation and Flu symptoms assessments, virological testing will be performed. Successfully screened participants will be stratified and randomized according to age (≥ 12 and < 18, ≥ 18, and ≤ 65 years), Weight (≥ 20 kg and < 80 kg, ≥ 80 kg), and randomized in a 1: 1 ratio to the investigational product or placebo group, with a single oral dose of 102D-6 dry suspension or placebo. Participants should complete baseline assessments of Body temperature, Flu symptoms, and health status prior to dosing.
After completion of dosing, the subject entered the safety follow-up period. On the day of dosing (D1) and on Days 2 to 14 of the follow-up period (D2 to D14), participants were required to receive the corresponding Investigation on the specified visit dates, and Body temperature, Flu symptoms, and health status were recorded daily.
On Day 15, participants were required to visit the study site for an end-of-study visit (EOS). If a participant withdraws prematurely from the study, he/she will be required to attend the study center for an Early Withdrawal Visit within 3 days of the decision to withdraw from the study.
- Conditions
- Influenza, Human
- Being tested
- 20 mg 102D-6 dry suspension, 40 mg 102D-6 dry suspension, Placebo
- Keywords
- Safety assessment, Efficacy evaluation
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20 mg 102D-6 dry suspensionDrug
Use only once during the whole study.
40 mg 102D-6 dry suspensionDrug
Use only once during the whole study.
PlaceboDrug
Use only once during the whole study.
| Study group | Role | What they receive |
|---|---|---|
| 102D-6 low dose group | Experimental | 20 mg of 102D-6 dry suspension Once during the whole study. Based on the analysis of phase II, arms not selected will be discontinued Receives: Drug: 20 mg 102D-6 dry suspension |
| 102D-6 high dose group | Experimental | 40 mg of 102D-6 dry suspension Once during the whole study. Based on the analysis of phase II, arms not selected will be discontinued Receives: Drug: 40 mg 102D-6 dry suspension |
| Placebo control | Placebo comparator | Analog dry suspension with no active ingredient. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase II:Viral RNA negative conversion time Phase III:time to alleviation of influenza symptoms
Phase II:Viral RNA negative conversion time Defined as the time from the start of treatment until the first time viral RNA (RT-PCR) is below the lower limit of quantification.
Phase III:time to alleviation of influenza symptoms defined as the time from the start of treatment until the patient's Body temperature normalized and all 7 flu symptomss (cough, sore throat, headache, nasal congestion, fever or chills, muscle or joint pain, fatigue) have alleviated (score 0 or 1).
Measured: from accepting drug until the 15 days after the first dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start21 Oct 2026 (estimated)
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza, HumanStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 570 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bin Cao, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07893847
- Sponsor's protocol ID
- TG2601102
- Status last verified
- Oct 2026
- First submitted
- 18 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multicenter, Phase II/III Study to Evaluate the Efficacy and Safety of 102D-6 in the Treatment of Uncomplicated Influenza.
- ClinicalTrials.gov ID
- NCT07893847
- Acronym / sponsor ID
- TG2601102
- Conditions
- Influenza, Human
- Keywords
- Safety assessment, Efficacy evaluation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 570 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 21 Oct 2026 (estimated)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 26 Oct 2026 (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 102D-6 in adolescents and adults with influenza.
The main aim to answer:
- Phase II study is to evaluate the efficacy of 102D-6 in the treatment of adult influenza subjects and determine the optimal therapeutic dose by analyzing the time of virus titer turning to negative. The results will be used to design the Phase III study.
- Phase III study is to evaluate the efficacy of 102D-6 by analyzing the duration of remission of all influenza symptoms in adolescents and adults subjects with influenza.
Participants will be taken 102D-6/Placebo once, and be observed by 15 days.
Detailed description
Phase II Screening and Treatment Period: screening Investigation and Flu symptoms assessments, virological testing will be performed. Successfully screened participants will be stratified and randomized according to Weight (≥ 20 kg and < 80 kg, ≥ 80 kg) in a 1: 1: 1 ratio to low dose, high dose, or PLACEBO, with a single oral dose of low dose 102D-6 dry suspension, high dose 102D-6 dry suspension, or placebo. Participants should complete baseline assessments of Body temperature, Flu symptoms, and health status prior to dosing.
After completion of dosing, the subject entered the safety follow-up period. On the day of dosing (D1) and on Days 2 to 14 of the follow-up period (D2 to D14), participants were required to receive the corresponding Investigation on the specified visit dates, and Body temperature, Flu symptoms, and health status were recorded daily.
On Day 15, participants were required to visit the study site for an end-of-observation visit (EOS). If a participant withdraws from the study early, he/she will be required to attend the study center for an early termination visit within 3 days of the decision to withdraw from the study.
Phase III Screening and Treatment Period: screening Investigation and Flu symptoms assessments, virological testing will be performed. Successfully screened participants will be stratified and randomized according to age (≥ 12 and < 18, ≥ 18, and ≤ 65 years), Weight (≥ 20 kg and < 80 kg, ≥ 80 kg), and randomized in a 1: 1 ratio to the investigational product or placebo group, with a single oral dose of 102D-6 dry suspension or placebo. Participants should complete baseline assessments of Body temperature, Flu symptoms, and health status prior to dosing.
After completion of dosing, the subject entered the safety follow-up period. On the day of dosing (D1) and on Days 2 to 14 of the follow-up period (D2 to D14), participants were required to receive the corresponding Investigation on the specified visit dates, and Body temperature, Flu symptoms, and health status were recorded daily.
On Day 15, participants were required to visit the study site for an end-of-study visit (EOS). If a participant withdraws prematurely from the study, he/she will be required to attend the study center for an Early Withdrawal Visit within 3 days of the decision to withdraw from the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 102D-6 low dose group | Experimental | Drug: 20 mg 102D-6 dry suspension20 mg of 102D-6 dry suspension Once during the whole study. Based on the analysis of phase II, arms not selected will be discontinued |
| 102D-6 high dose group | Experimental | Drug: 40 mg 102D-6 dry suspension40 mg of 102D-6 dry suspension Once during the whole study. Based on the analysis of phase II, arms not selected will be discontinued |
| Placebo control | Placebo comparator | Drug: PlaceboAnalog dry suspension with no active ingredient. |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (26 listed)
- Aged 18 to 65 years (including cut-off value), male or female;
- Patients in the screening period met the following criteria:
- The first occurrence of influenza symptoms ≤ 48 hours from the time of patient randomization.
- Aged 12 to 65 years (including cut-off value), male or female;
- Patients in the screening period met the following criteria:
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| 20 mg 102D-6 dry suspensionUse only once during the whole study. | Drug | 102D-6 low dose group |
| 40 mg 102D-6 dry suspensionUse only once during the whole study. | Drug | 102D-6 high dose group |
| PlaceboUse only once during the whole study. | Drug | Placebo control |
Primary outcome
Phase II:Viral RNA negative conversion time Phase III:time to alleviation of influenza symptoms
Time frame: from accepting drug until the 15 days after the first dosing
Phase II:Viral RNA negative conversion time Defined as the time from the start of treatment until the first time viral RNA (RT-PCR) is below the lower limit of quantification. Phase III:time to alleviation of influenza symptoms defined as the time from the start of treatment until the patient's Body temperature normalized and all 7 flu symptomss (cough, sore throat, headache, nasal congestion, fever or chills, muscle or joint pain, fatigue) have alleviated (score 0 or 1).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- 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.
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 20 mg 102D-6 dry suspension and 40 mg 102D-6 dry suspension in people with Influenza, Human, run by Capital Medical University 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 26 inclusion and 0 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: opening soon, as of the sponsor's last update on 26 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bin Cao, MD (18801663558, caobin_ben@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase II:Viral RNA negative conversion time Phase III:time to alleviation of influenza symptoms (time frame: from accepting drug until the 15 days after the first dosing). 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 26 Oct 2026.