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Status:

COMPLETED

A Study of AK0529 in Adults Patients Hospitalized With RSV Infection

Lead Sponsor:

Shanghai Ark Biopharmaceutical Co., Ltd.

Conditions:

Respiratory Syncytial Virus Infections

Eligibility:

All Genders

18-85 years

Phase:

PHASE2

Brief Summary

This is a randomized, double-blind, placebo-controlled, multicenter, phase II study to be conducted in adults hospitalized with RSV infection in China. The main objectives of this study are to investi...

Eligibility Criteria

Inclusion

  • Main Inclusion criteria:
  • . Male or female patients of any ethnicity with an age of 18-85 years.
  • . Diagnosis of RSV infection by any virological means within 36 hours preceding initial dosing.
  • . At least one of the following high-risk diseases or states for RSV infection
  • Asthma or chronic lung disease (such as COPD or cystic fibrosis),
  • immunocompromised,
  • Heart disease (such as congenital heart disease, congestive, heart failure, or coronary artery disease), except high blood, pressure without heart-related symptoms,
  • Chronic kidney disease,
  • Age ≥65 years old.
  • . With at least 1 new onset respiratory infection symptom or exacerbation of existing respiratory symptoms (respiratory symptoms include: sore throat, nasal congestion, runny nose, sneezing, coughing, wheezing, sputum production, shortness of breath), and any individual score is 2 or moderate.
  • . Onset of RSV infection symptoms should be ≤ 7 days.
  • Main Exclusion criteria:
  • . 3 days for drugs with potential antiviral effects on RSV such as ordinary interferon, 8 days for long-acting interferon, and 35 days for ribavirin for 5 half-lives before expected administration.
  • . Prohibited medicine are being used or planned to be used during the study treatment periods.
  • . Severe gastrointestinal diseases that affect the absorption of study drugs (such as vomiting, malabsorption syndrome, short bowel syndrome due to necrotizing enterocolitis, etc.).
  • . Received or planned to have bone marrow transplantation, stem cell transplantation or solid organ transplantation within 1 year.
  • . Patients with malignant tumors who had surgery within recent 6 months and/or requiring radiotherapy, chemotherapy and biological immunotherapy.
  • . Patients with autoimmune diseases who are in the induction treatment.
  • . HIV infection, CD4 count\< 350 cells/mm3 with opportunistic infection and need treatment.
  • . Other patients who are judged by the investigator to be unsuitable for participating in the study, such as acute/chronic heart, lung, liver, kidney, rheumatic immunity, psychiatric, blood and other diseases in the unstable period.
  • . History of drug abuse within 12 months prior to screening.
  • . Allergy to the investigational drug or its component.
  • . Female patients with positive pregnancy test or breastfeeding.

Exclusion

    Key Trial Info

    Start Date :

    July 20 2023

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    June 28 2024

    Estimated Enrollment :

    25 Patients enrolled

    Trial Details

    Trial ID

    NCT06942299

    Start Date

    July 20 2023

    End Date

    June 28 2024

    Last Update

    April 24 2025

    Active Locations (42)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 11 (42 locations)

    1

    The Second Perople's Hospital of Hefei

    Hefei, Anhui, China

    2

    Huangshan City People's Hospital

    Huangshan City, Anhui, China

    3

    Peking University Shougang Hospital

    Beijing, Beijing Municipality, China, 100000

    4

    Beijing Hospital

    Beijing, Beijing Municipality, China, 100005