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Not yet recruitingNCT07893847Updated Oct 26, 2026

Evaluation of the Efficacy and Safety of 102D-6 in the Treatment of Acute Uncomplicated Influenza

A Phase 2/3 interventional study of 20 mg 102D-6 dry suspension and 40 mg 102D-6 dry suspension in Influenza, Human, sponsored by Capital Medical University. Not yet recruiting at 1 site in China. Open to participants aged 12 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-26.

Sponsored by Capital Medical University · Phase 2/3, Interventional, and Treatment

Updated Oct 26, 2026Newly registeredGo to Updates ↓
Phase
Phase 2/3
Study type
Interventional
Enrollment
570
Allocation
Randomized
Ages
12 Years to 65 Years
Sex
All
01

Study 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 of virus titer turning to negative. The results will be used to design the Phase III study.
  2. 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.

02

Conditions studied

  • Influenza, Human

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Keywords

  • Safety assessment
  • Efficacy evaluation
03

In context

Influenza, Human

2,264 studies on the registry are indexed under Influenza, Human; 173 are open to participants now.

This study's planned enrollment of 570 is above the median of 240 across 1,894 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

Capital Medical University is the lead sponsor of 294 studies on the registry; 92 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria for Part I

  1. Aged 18 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;
    • 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;
  3. The first occurrence of influenza symptoms ≤ 48 hours from the time of patient randomization.

Inclusion Criteria for Part II

  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.

Inclusion Criteria for Part I

  1. Aged 18 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;
    • 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;
  3. The first occurrence of influenza symptoms ≤ 48 hours from the time of patient randomization.

Inclusion Criteria for Part II

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.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
570 participants (estimated)

Study arms

  • Experimental
    102D-6 low dose group

    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

    Drug: 20 mg 102D-6 dry suspension

  • Experimental
    102D-6 high dose group

    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

    Drug: 40 mg 102D-6 dry suspension

  • Placebo comparator
    Placebo control

    Analog dry suspension with no active ingredient.

    Drug: Placebo

Interventions

  • Drug20 mg 102D-6 dry suspension

    Use only once during the whole study.

  • Drug40 mg 102D-6 dry suspension

    Use only once during the whole study.

  • DrugPlacebo

    Use only once during the whole study.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: from accepting drug until the 15 days after the first dosing

07

Study locations

1 site
  • China-Japan Friendship Hospital
    Beijing, Beijing Municipality 100029, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Mar 2027, 5 months later.

Of 12 phase 2/3 interventional studies under Influenza, Human, half reached primary completion within 8 months of starting (the median); a quarter within 5 and three quarters within 10. This study's planned 5 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 18, 2026
First posted
Oct 26, 2026
StartEst.
Oct 21, 2026
Primary completionEst.
Mar 30, 2027
CompletionEst.
Mar 30, 2027
Last update
Oct 26, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 26, 2026
Show all 1 update
  1. Oct 26, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07893847
Lead sponsor
Capital Medical University
Responsible party
Bin Cao (Professor, Capital Medical University) — Principal investigator
First posted
Oct 26, 2026
Start date
Oct 21, 2026 (estimated)
Primary completion
Mar 30, 2027 (estimated)
Completion
Mar 30, 2027 (estimated)
Last update
Oct 26, 2026

Study contacts

Bin Cao, MD
Contact
caobin_ben@163.com
18801663558
Yeming Wang, PhD
Contact
wyymm_love@163.com
18801663558

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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