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Respiratory Syncytial Virus InfectionsPhase 2NCT06942299

A Study of AK0529 in Adults Patients Hospitalized With RSV Infection

A Phase 2 study testing AK0529 in people with Respiratory Syncytial Virus Infections, run by Shanghai Ark Biopharmaceutical Co., Ltd. at 42 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 investigate the safety, pharmacokinetics and efficacy of AK0529 in adult RSV patients. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Respiratory Syncytial Virus Infections
What is being tested?
AK0529
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
25 participants
Where
42 sitesChina
Study dates
20 Jul 2023to 28 Jun 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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
  4. Asthma or chronic lung disease (such as COPD or cystic fibrosis),
  5. immunocompromised,
  6. Heart disease (such as congenital heart disease, congestive, heart failure, or coronary artery disease), except high blood, pressure without heart-related symptoms,
  7. Chronic kidney disease,
  8. Age ≥65 years old.
  9. . 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.
  10. . 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 locations and contacts

42 sites in 1 country.

42 sites in 1 country

China42 sites

  • Peking University Shougang Hospital

    Beijing, Beijing Municipality, 100000

  • Beijing Hospital

    Beijing, Beijing Municipality, 100005

  • China-Japan Friendship Hospital

    Beijing, Beijing Municipality, 100029

  • Jilin Province People's Hospital

    Changchun, Jilin

  • Changzhou Second People's Hospital

    Changzhou, Jiangsu, 213004

  • Chengdu Seventh People's Hospital

    Chengdu, Sichuan, 610044

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, 350004

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510120

  • Guangzhou Panyu Central Hospital

    Guangzhou, Guangdong, 511486

  • Guizhou People's Hospital

    Guiyang, Guizhou

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang, 314408

  • Harbin Medical University Affiliated Fourth Hospital

    Harbin, Heilongjiang

  • The Second Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine

    Harbin, Heilongjiang

  • The Second Perople's Hospital of Hefei

    Hefei, Anhui

  • Inner Mongolia Autonomous Region People's Hospital

    Hohhot, Neimenggu

  • Huangshan City People's Hospital

    Huangshan City, Anhui

  • The First Hospital of Kunming

    Kunming, Yunnan

  • The First People's Hospital of Yunnan Province

    Kunming, Yunnan

  • Gansu People's Hospital

    Lanzhou, Gansu

  • The First Affilited Hospital of Nanchang University

    Nanchang, Jiangxi

  • Jiangsu Provincial Hospital of Chinese Medicine

    Nanjing, Jiangsu, 210004

  • The Second Nanning People's Hospital

    Nanning, Guangxi

  • Ningbo First Hospital

    Ningbo, Zhejiang, 315010

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong

  • Quanzhou First Hospital

    Quanzhou, Fujian

  • Tongji Hospital of Tongji University

    Shanghai, Shanghai Municipality, 200065

  • Yueyang Hospital Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

    Shanghai, Shanghai Municipality, 200437

  • Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

    Shanghai, Shanghai Municipality, 201203

  • Shaoxing People's Hospital

    Shaoxing, Zhejiang, 312035

  • The First Clinical College / Liaoning Hospital of TCM

    Shenyang, Liaoning

  • Longgang Central Hospital of Shenzhen

    Shenzhen, Guangdong, 518116

  • Hebei Chest Hospital

    Shijiazhuang, Hebei

  • Shunde Hospital of Southern Medical University

    Shunde, Guangdong, 528399

  • Sencond Hospital of Shanxi Medical University

    Taiyuan, Shanxi

  • Taizhou Hospital of Zhejiang Province

    Taizhou, Zhejiang, 317099

  • Weifang NO.2 People's Hospital

    Weifang, Shandong

  • Wuhan Fourth Hospital

    Wuhan, Hubei

  • The First Affiliated Hospital of Xi'an Medical University

    Xi’an, Shanxi

  • Xiangyang Center Hospital

    Xiangyang, Hubei

  • Yueyang Central Hospital

    Yueyang, Hunan

  • Central People's Hospital of Zhanjiang

    Zhanjiang, Guangdong, 524037

  • The Sixth People's Hospital of Zhengzhou

    Zhengzhou, Henan

Other trials in China

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Study Evaluating the Pharmacokinetics, Safety, and Efficacy of Multiple Doses AK0529 in Adult Hospitalized Subjects With Respiratory Syncytial Virus Infection

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.

Being tested
AK0529, Placebo
Keywords
Adult patient with RSV infection, High-risk disease, AK0529
Medical subject headings
Respiratory Syncytial Virus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AK0529Drug

    Active Substance: AK0529, Pharmaceutical Form: Enteric pellets, Route of Administration: Oral, fasting

  • AK0529Drug

    Active Substance: AK0529, Pharmaceutical Form: Enteric pellets, Route of Administration: Oral with meal

  • PlaceboDrug

    Active Substance: Placebo, Pharmaceutical Form: Enteric pellets, Route of Administration: Oral with meal or fasting

Study groups in NCT06942299
Study groupRoleWhat they receive
Active drug: AK0529 fastingExperimentalThe participants will receive AK0529 twice daily for 5 days from D1 to D5.
Receives: Drug: AK0529
Active drug: AK0529 with mealExperimentalThe participants will receive AK0529 twice daily for 5 days from D1 to D5.
Receives: Drug: AK0529
PlaceboPlacebo comparatorPlacebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence and severity of AE and SAE of subjects during the study period

    An Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect, or another important medical event.

    Measured: Baseline up to 28 days

Secondary outcomes (18)

  1. Change from baseline in clinical improvement score of subjects at each visit after treatment by clinical improvement scale

    Clinical improvement scale is mainly used to evaluate the overall severity level of the subject's disease with the highest score of 8 indicating death. A score of 6-7 represents severe hospitalization: a score of 6 requires mechanical ventilation, and a score of 7 requires not only mechanical ventilation but also angiogenic treatment, kidney dialysis, or artificial membrane lung. A score of 3-5 represents mild hospitalization: a score of 3 does not require oxygen therapy, a score of 4 requires a mask or nasal catheter, and a score of 5 requires noninvasive positive pressure ventilation or high-flow oxygen therapy. A score of 1-2 represents outpatient treatment: 1 is independent and 2 is in need of care (daily activities have an impact). A score of 0 means no treatment is required and there is no clinical or virological evidence of infection.

    Measured: Baseline up to 28 days

  2. Change from baseline in RiiQ symptoms of subjects at each visit after treatment measured by RiiQ questionnaire

    RiiQ questionnaire is mainly used to assess RSV symptoms in patients, including upper respiratory tract infection symptoms (sore throat and nasal congestion), symptoms of lower respiratory tract infection (cough, wheezing, sputum, shortness of breath), and system symptoms (fever, headache, neck pain, fatigue, lack of appetite, interrupted sleep, body aches). The questionnaire is divided into four grading categories of severity including none (0), mild (1), moderate (2) and severe (3).

    Measured: Baseline up to 28 days

  3. Changes from baseline in the total score of RSV Symptom of subjects at each visit after treatment using RSV Symptom Score Composite Scale

    RSV Symptom Score Composite Scale is used to assess patients with RSV symptoms, including runny nose, stuffy nose, sneezing, sore throat, earache, cough, shortness of breath, headache, fatigue, myalgia and/or joint pain. The score is divided into 4 grades according to the severity of symptoms. 0 indicates no symptoms, 1 indicates occasional symptoms, 2 indicates that symptoms sometimes worsen significantly but do not affect daily activities, and 3 indicates that symptoms are always serious and cannot engage in daily activities. The total score is 30 points.

    Measured: Baseline up to 28 days

  4. Changes from baseline in the RSV VL (viral load) of subjects at each visit after treatment

    The RSV VL of subjects' nasopharyngeal samples is measured as Log10 copies/mL by quantitative reverse transcription polymerase chain reaction (qRT-PCR).

    Measured: Baseline up to 28 days

  5. Area under the curve (AUCE, last) of RSV Viral Load from baseline to the last measurement

    The RSV VL is measured as Log10 copies/mL by qRT-PCR assay in the nasopharyngeal specimens.

    Measured: Baseline up to 28 days

  6. Number of subjects with RSV VL values below the lower limit of quantitation (LLOQ) at each visit after treatment

    The RSV VL is measured as Log10 copies/mL by qRT-PCR assay in the nasopharyngeal specimens.

    Measured: Baseline up to 28 days

  7. Number of participants who dropped out of the study due to AE

    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.

    Measured: Baseline up to 28 days

  8. Number of participants with laboratory examination abnormalities

    Following parameters were analyzed for laboratory examination: hemoglobin (Hb), hematocrit, platelet count, red blood cell (RBC) count, white blood cell (WBC) count, mean corpuscular volume (MCV) and absolute white blood cell line (neutrophils, eosinophils, lymphocytes, monocytes, basophils); Hepatobiliary biochemistry: total and direct bilirubin, total protein, albumin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP); Renal Function Tests: creatinine kinase, uric acid ; Electrolytes: Sodium, Potassium; Glucose; Coagulation function (subjects with only a history of liver disease should be tested): international normalized ratio (INR), activated partial thromboplastin time, prothrombin time, thrombin time, and fibrinogen; Urine analysis: urine protein, ketone bodies, urine red blood cells, urine white blood cells, and urine glucose; Blood or urine pregnancy test for all female subjects.

    Measured: Baseline up to 28 days

  9. Number of participants with vital sign abnormalities

    Number of participants with vital sign (systolic and diastolic blood pressure, pulse rate, respiratory rate, temperature and oxygen saturation) abnormalities were reported.

    Measured: Baseline up to 28 days

  10. Number of participants with physical examination abnormalities

    A comprehensive physical examination includes at least cardiovascular, respiratory, gastrointestinal, and nervous system assessments; a simple physical examination includes at least skin, lung, cardiovascular system and abdominal (liver and spleen) assessments.

    Measured: Baseline up to 28 days

  11. Number of participants with ECG abnormalities

    Electrocardiograms were measured during the screening period, at 4 (±1) hours after the first dose on day 2, at 4 (±1) hours and 12 (±1) hours (before the second dose) after the first dose on day 4, and once on day 6 and day 14 during the follow-up period; 9-or 12-lead ECG results are recorded using an ECG instrument which automatically calculates heart rate and measures PR, QRS, QT and QTc intervals.

    Measured: Baseline up to 28 days

  12. Peak Plasma Concentration (Cmax)

    Whole blood of subjects (2 mL per time point) was collected for the concentration determination of the AK0529 and its metabolites at various time points on day 1 and day 5, and the PK parameter is calculated using the above-mentioned plasma concentration data.

    Measured: Day 1, Day 5

  13. Time to Maximum Plasma Concentration (Tmax)

    Whole blood of subjects (2 mL per time point) was collected for the concentration determination of the AK0529 and its metabolites at various time points on day 1 and day 5, and the PK parameter is calculated using the above-mentioned plasma concentration data.

    Measured: Day 1，Day 5

  14. Terminal Elimination Half-life (t½)

    Whole blood of subjects (2 mL per time point) was collected for the concentration determination of the AK0529 and its metabolites at various time points on day 1 and day 5, and the PK parameter is calculated using the above-mentioned plasma concentration data.

    Measured: Day 1，Day 5

  15. Apparent Clearance (CL/F)

    Whole blood of subjects (2 mL per time point) was collected for the concentration determination of the AK0529 and its metabolites at various time points on day 1 and day 5, and the PK parameter is calculated using the above-mentioned plasma concentration data.

    Measured: Day 1，Day 5

  16. Apparent Volume of Distribution (V[z]/F)

    Whole blood of subjects (2 mL per time point) was collected for the concentration determination of the AK0529 and its metabolites at various time points on day 1 and day 5, and the PK parameter is calculated using the above-mentioned plasma concentration data.

    Measured: Day 1，Day 5

  17. Area Under the Plasma Concentration-Time Curve From Time 0 to 12 (AUC[0-12])

    Whole blood of subjects (2 mL per time point) was collected for the concentration determination of the AK0529 and its metabolites at various time points on day 1 and day 5, and the PK parameter is calculated using the above-mentioned plasma concentration data.

    Measured: Day 1，Day 5

  18. Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞])

    Whole blood of subjects (2 mL per time point) was collected for the concentration determination of the AK0529 and its metabolites at various time points on day 1 and day 5, and the PK parameter is calculated using the above-mentioned plasma concentration data.

    Measured: Day 1，Day 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2025
  2. Study start20 Jul 2023
  3. Primary completion28 Jun 2024
  4. Study completion28 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This clinical study is a randomized placebo controlled parallel multi-center phase II trial.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06942299
Sponsor's protocol ID
AK0529-2005
Status last verified
Apr 2025
First submitted
24 Mar 2023
Last updated
24 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AK0529 in people with Respiratory Syncytial Virus Infections, run by Shanghai Ark Biopharmaceutical Co., Ltd. at 42 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and severity of AE and SAE of subjects during the study period (time frame: Baseline up to 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06942299.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.

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