A Study of AK0529 in Adults Patients Hospitalized With RSV Infection

Shanghai Ark Biopharmaceutical

Status and phase: Completed; Phase 2

Conditions: Respiratory Syncytial Virus Infections

Treatments: Drug: Placebo; Drug: AK0529

Study type: Interventional

Funder types: Industry

Identifiers

NCT06942299

AK0529-2005

Details and patient eligibility

About

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 investigate the safety, pharmacokinetics and efficacy of AK0529 in adult RSV patients.

Enrollment: 25 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion criteria:

1. . Male or female patients of any ethnicity with an age of 18-85 years.

2. . Diagnosis of RSV infection by any virological means within 36 hours preceding initial dosing.

3. . At least one of the following high-risk diseases or states for RSV infection

   1. Asthma or chronic lung disease (such as COPD or cystic fibrosis),
   2. immunocompromised,
   3. Heart disease (such as congenital heart disease, congestive, heart failure, or coronary artery disease), except high blood, pressure without heart-related symptoms,
   4. Chronic kidney disease,
   5. Age ≥65 years old.

4. . 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.

5. . Onset of RSV infection symptoms should be ≤ 7 days.

Main Exclusion criteria:

1. . 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.
2. . Prohibited medicine are being used or planned to be used during the study treatment periods.
3. . Severe gastrointestinal diseases that affect the absorption of study drugs (such as vomiting, malabsorption syndrome, short bowel syndrome due to necrotizing enterocolitis, etc.).
4. . Received or planned to have bone marrow transplantation, stem cell transplantation or solid organ transplantation within 1 year.
5. . Patients with malignant tumors who had surgery within recent 6 months and/or requiring radiotherapy, chemotherapy and biological immunotherapy.
6. . Patients with autoimmune diseases who are in the induction treatment.
7. . HIV infection, CD4 count< 350 cells/mm3 with opportunistic infection and need treatment.
8. . 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.
9. . History of drug abuse within 12 months prior to screening.
10. . Allergy to the investigational drug or its component.
11. . Female patients with positive pregnancy test or breastfeeding.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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25 participants in 3 patient groups, including a placebo group

Active drug: AK0529 fasting

Experimental group

Description:

The participants will receive AK0529 twice daily for 5 days from D1 to D5.

Treatment:

Drug: AK0529

Drug: AK0529

Active drug: AK0529 with meal

Experimental group

Description:

The participants will receive AK0529 twice daily for 5 days from D1 to D5.

Treatment:

Drug: AK0529

Drug: AK0529

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo