Clinical Trials in China / NCT07893847
Starting soon
Phase 2/3
Evaluation of the Efficacy and Safety of 102D-6 in the Treatment of Acute Uncomplicated Influenza
NCT07893847 · tracked via the Priya Life Science China tracker
Condition(s) studied
Influenza, Human
Investigational drug(s) / intervention(s)
20 mg 102D-6 dry suspension40 mg 102D-6 dry suspensionPlacebo
20 mg 102D-6 dry suspension: Use only once during the whole study.
40 mg 102D-6 dry suspension: Use only once during the whole study.
Placebo: Use only once during the whole study.
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.
Eligibility
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.
Primary outcome measure(s)
- Phase II:Viral RNA negative conversion time Phase III:time to alleviation of influenza symptoms — 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).
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| China-Japan Friendship Hospital | Beijing | Beijing Municipality |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07893847 on ClinicalTrials.gov ↗ ← All trials in China