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ADC189 Tablets on Influenza A Virus Infection/Influenza B Virus Infection

NCT06342921 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 749

Last updated 2025-01-21

No results posted yet for this study

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.

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.

Conditions

  • Safety Issues
  • Effect of Drug

Interventions

DRUG

15 mg ADC189

Use only once during the whole study.

DRUG

45 mg ADC189

Use only once during the whole study.

DRUG

Placebo

Use only once during the whole study.

Sponsors & Collaborators

  • Jiaxing AnDiCon Biotech Co.,Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-07
Primary Completion
2023-10-08
Completion
2024-01-22

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06342921 on ClinicalTrials.gov