Respiratory Synctial Virus InfectionsPhase 3NCT06775405
A Study to Confirm the Effectiveness and Safety of AK0529 in Treating RSV Infections in Hospitalized Infants
A Phase 3 study testing AK0529 in people with Respiratory Synctial Virus Infections, run by Shanghai Ark Biopharmaceutical Co., Ltd. at 17 sites in China.
Trial summary
Respiratory syncytial virus (RSV) is the most common respiratory infectious pathogen recognized worldwide that poses serious health risks to infants, and an important cause of hospitalization for severe respiratory infections in infants. Read more about this study
- Who is it for?
- Ages 1 month to 24 months
- Conditions the study is for
- Respiratory Synctial 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
- 180 participants
- Where
- 17 sitesChina
- Study dates
- 29 Feb 2024to 16 Apr 2025
- Phase
- Phase 3
- 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 1 month to 24 months
- All sexes
- No healthy volunteers
- Child
Main Inclusion criteria:
- Male or female subjects of any ethnicity with an age adjusted for any prematurity of ≥1 month and ≤24 months.
- Diagnosis of RSV infection by any virological means, including a rapid diagnostic point-of-care testing, within 36 hours preceding initial dosing.
- The onset of RSV infection symptoms should be ≤ 5 days prior to initial dosing.
- Subject must weigh ≥ 2.5 kg and ≤ 20 kg at screening and be within the normal range for the subject's age, based on local child growth standards.
- Subject must have a Wang bronchiolitis clinical score ≥ 5.
Main Exclusion criteria:
- The subject has taken any restricted medications within 3 days prior to the date of screening or requires any restricted medications during treatment phase (including interferons, ribavirin, or proprietary Chinese medicines with antiviral effects) and has taken any inhaled or systemic glucocorticoids within 24 hours.
- Subject is known to have co-infection with influenza virus, Mycoplasma, or other respiratory tract pathogens that require targeted clinical treatment .
- Subject is known to have bacterial pneumonia.
- Subject with clinical evidence of hepatic decompensation (e.g., liver disease with coagulation abnormalities or encephalopathy).
- Subject with inborn symptoms of metabolic abnormalities (e.g., mitochondrial diseases, carbohydrate metabolism abnormalities, glycogen accumulation diseases).
- Subject with chronic or persistent feeding difficulties.
- The parent or guardian of the subject is an employee of the study investigator or the study facility (such person will be directly involved in the study or any other study administered by the study facility investigator), or a family member of the study investigator or his/her staff.
- Subject who have participated in clinical trials of other drugs or devices in the 30 days prior to screening.
- Subject with any other reason that the investigator deems unsuitable for participation in the study.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
China17 sites
Beijing Children's Hospital, Capital Medical University
Beijing
First Hospital of Jilin University
Changchun
Hunan Provincial People's Hospital
Changsha
West China Second University Hospital, Sichuan University
Chengdu
Children's Hospital, Zhejiang University School of Medicine
Hangzhou
Sanya Central Hospital, Hainan Third People's Hospital
Sanya
Shanghai Children's Hospital, Shanghai Jiao Tong University
Shanghai
Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine
Shanghai
Shengjing Hospital of China Medical University
Shenyang
Tianjin Children's Hospital（Longyan）
Tianjin
Tianjin Children's Hospital（Machang）
Tianjin
Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou
Wuhan Children's Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan
Wuxi Children's Hospital
Wuxi
First Affiliated Hospital of Xiamen University
Xiamen
Women and Children's Hospital, and the School of Medicine, Xiamen University
Xiamen
Zhongshan Women and Children's Hospital-Zhongshan Boai Hospital
Zhongshan
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Phase III Confirmatory Study to Evaluate the Efficacy, Safety, Tolerability, and Antiviral Activity of Repeated Oral Administration of AK0529 in Hospitalized Infants With Respiratory Syncytial Virus Infection
Respiratory syncytial virus (RSV) is the most common respiratory infectious pathogen recognized worldwide that poses serious health risks to infants, and an important cause of hospitalization for severe respiratory infections in infants. Serious respiratory problems such as pneumonia caused by RSV are one of the leading causes of death from respiratory diseases in infants. AK0529 targets the Pre-F (fusion) protein on the surface of the viral envelope. Specifically, it prevents the virus from invading uninfected cells and inhibits the fusion between host cells by inhibiting the fusion of the F (fusion) proteins on the surface of the RSV envelope, thus providing the effects of anti-RSV infection. This is a randomized, double-blind, placebo-controlled, multicenter, phase III clinical study to evaluate the efficacy and safety of AK0529 in hospitalized infants aged 1 to 24 months with RSV infection. Considering the benefits of AK0529 in the population with RSV infection, hospitalized infants with moderate to severe RSV infection were selected as the target population for this study.
Read the detailed description
This is a Phase III, randomized, double-blind, placebo-controlled, multicenter clinical study conducted among Chinese infants aged 1 to 24 months hospitalized with Respiratory Syncytial Virus (RSV) infection.
The study plans to enroll 180 infants aged 1 to 24 months with RSV infection. Eligible subjects will be randomized in a 1:1 ratio (AK0529: placebo). These subjects will receive the study drug twice daily for 5 consecutive days and the dose depends on subject's weight range.
Each subject in this study will undergo a visit schedule comprising a screening period of 36 hours before the first dose, a 5-day double-blinded treatment period, and a 9-day safety follow-up period after the last dose of treatment. The expected duration of participation for each subject will not exceed 17 days.
Infants successfully enrolled in this study will take the medication every 12 hours for 5 consecutive days, in total 10 doses. Investigators will regularly score the infants using the Wang bronchiolitis clinical score which is the primary endpoint. Additionally, nasopharyngeal aspirates samples will be collected from the infants for virological testing before the first dose on Days 1 to 5, on Day 6, and on Day 14.
Safety and tolerability assessments in this study will include evaluations of adverse events (AEs)/serious adverse events (SAEs), vital signs and blood oxygen saturation (SpO2) levels, physical examinations, clinical laboratory tests, and electrocardiogram (ECG) findings.
- Conditions
- Respiratory Synctial Virus Infections
- Being tested
- AK0529, Placebo
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
PlaceboDrug
Active Substance: Placebo, Pharmaceutical Form: Enteric pellets, Route of Administration: Oral
| Study group | Role | What they receive |
|---|---|---|
| Active drug | Experimental | The participants will receive AK0529 of 10 mg, 20 mg or 40 mg based on body weight twice daily for 5 days from D1 to D5. Receives: Drug: AK0529 |
| Placebo | Placebo comparator | The participants will receive placebo of 10 mg, 20 mg or 40 mg based on body weight twice daily for 5 days from D1 to D5. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the Wang bronchiolitis clinical score
The Wang bronchiolitis clinical score will be used to evaluate respiratory rate, wheezing, respiratory muscle retraction and "general condition" (sleep, feeding, and general status) in subjects with symptoms of bronchiolitis. Each item of the scale is divided into 4 levels according to the severity of symptoms, with 0 point indicating normal and 3 points the highest severity, 12 points in total.
Measured: Day 3 (48 hours)
Secondary outcomes (9)
Change from baseline in the Wang bronchiolitis clinical score in subjects younger than 6 months.
The Wang bronchiolitis clinical score will be used to evaluate respiratory rate, wheezing, respiratory muscle retraction and "general condition" (sleep, feeding, and general status) in subjects with symptoms of bronchiolitis. Each item of the scale is divided into 4 levels according to the severity of symptoms, with 0 point indicating normal and 3 points the highest severity, 12 points in total.
Measured: Day 3 (48 hours)
Time from first treatment to sustained remission of symptoms during the treatment period.
The sustained remission is defined as achieving a total Wang bronchiolitis clinical score of 0 or 1 for 48 consecutive hours without support of oxygen therapy.
Measured: Study period (up to 14 days)
Change in RSV VL (viral load) from baseline at each visit.
The viral load of subjects' nasopharyngeal samples will be measured by quantitative reverse transcription polymerase chain reaction (qRT-PCR).
Measured: Day 2, Day 3, Day 4, Day 5, Day 6, Day 14
Proportion of subjects with RSV VL below the lower limit of quantitation (LLOQ) at each visit.
The viral load of subjects' nasopharyngeal samples will be measured by quantitative reverse transcription polymerase chain reaction (qRT-PCR).
Measured: Day 2, Day 3, Day 4, Day 5, Day 6, Day 14
Time from first treatment to mild disease for subjects, defined as achieving a Wang bronchiolitis clinical score ≤ 3 without the need for supplemental oxygen.
Measured: Study period (up to 14 days)
Change in sub-scores of the Wang bronchiolitis clinical score from baseline at each visit.
The Wang bronchiolitis clinical score will be used to evaluate respiratory rate, wheezing, respiratory muscle retraction and "general condition" (sleep, feeding, and general status) in subjects with symptoms of bronchiolitis. Each item of the scale is divided into 4 levels according to the severity of symptoms, with 0 point indicating normal and 3 points the highest severity, 12 points in total.
Measured: Day 2, Day 3, Day 4, Day 5, Day 6, Day 14
Time from initial dosing to resolution of symptoms based on sub-scores of the Wang bronchiolitis clinical score.
The resolution is defined as achieving the following sub-scores without the need for supplemental oxygen:
- Respiratory rate = 0 or 1
- Wheezing = 0 or 1
- Respiratory muscle retraction = 0 or 1
- General condition = 0 Note: The above indicators are only for subjects with a baseline sub-score greater than 0 for the respective sub-scores.
Measured: Study period (up to 14 days)
Safety endpoints
The safety assessment includes the following events, tests, indicators occurring during the study process:
- Incidence rate and severity of Adverse Events (AEs), Serious Adverse Events (SAEs), and withdrawal from the study due to AEs;
- Laboratory tests;
- Electrocardiogram (ECG);
- Physical examination and vital signs.
Measured: Study period (up to 14 days)
Pharmacokinetic endpoints
Include but not limit to steady state AUC, Cmax and Ctrough.
Measured: Study period (up to 14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start29 Feb 2024
- Primary completion7 Apr 2025
- Study completion16 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Synctial Virus InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This clinical study is a randomized placebo controlled parallel multi-center phase III trial.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Ark Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06775405
- Sponsor's protocol ID
- AK0529-2007
- Status last verified
- Oct 2026
- First submitted
- 16 Dec 2024
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Phase III Confirmatory Study to Evaluate the Efficacy, Safety, Tolerability, and Antiviral Activity of Repeated Oral Administration of AK0529 in Hospitalized Infants With Respiratory Syncytial Virus Infection
- ClinicalTrials.gov ID
- NCT06775405
- Acronym / sponsor ID
- AK0529-2007
- Conditions
- Respiratory Synctial Virus Infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Shanghai Ark Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Feb 2024 (actual)
- Primary completion
- 7 Apr 2025 (actual)
- Study completion
- 16 Apr 2025 (actual)
- First posted
- 15 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Respiratory syncytial virus (RSV) is the most common respiratory infectious pathogen recognized worldwide that poses serious health risks to infants, and an important cause of hospitalization for severe respiratory infections in infants. Serious respiratory problems such as pneumonia caused by RSV are one of the leading causes of death from respiratory diseases in infants. AK0529 targets the Pre-F (fusion) protein on the surface of the viral envelope. Specifically, it prevents the virus from invading uninfected cells and inhibits the fusion between host cells by inhibiting the fusion of the F (fusion) proteins on the surface of the RSV envelope, thus providing the effects of anti-RSV infection. This is a randomized, double-blind, placebo-controlled, multicenter, phase III clinical study to evaluate the efficacy and safety of AK0529 in hospitalized infants aged 1 to 24 months with RSV infection. Considering the benefits of AK0529 in the population with RSV infection, hospitalized infants with moderate to severe RSV infection were selected as the target population for this study.
Detailed description
This is a Phase III, randomized, double-blind, placebo-controlled, multicenter clinical study conducted among Chinese infants aged 1 to 24 months hospitalized with Respiratory Syncytial Virus (RSV) infection.
The study plans to enroll 180 infants aged 1 to 24 months with RSV infection. Eligible subjects will be randomized in a 1:1 ratio (AK0529: placebo). These subjects will receive the study drug twice daily for 5 consecutive days and the dose depends on subject's weight range.
Each subject in this study will undergo a visit schedule comprising a screening period of 36 hours before the first dose, a 5-day double-blinded treatment period, and a 9-day safety follow-up period after the last dose of treatment. The expected duration of participation for each subject will not exceed 17 days.
Infants successfully enrolled in this study will take the medication every 12 hours for 5 consecutive days, in total 10 doses. Investigators will regularly score the infants using the Wang bronchiolitis clinical score which is the primary endpoint. Additionally, nasopharyngeal aspirates samples will be collected from the infants for virological testing before the first dose on Days 1 to 5, on Day 6, and on Day 14.
Safety and tolerability assessments in this study will include evaluations of adverse events (AEs)/serious adverse events (SAEs), vital signs and blood oxygen saturation (SpO2) levels, physical examinations, clinical laboratory tests, and electrocardiogram (ECG) findings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This clinical study is a randomized placebo controlled parallel multi-center phase III trial.
| Arm | Type | Receives |
|---|---|---|
| Active drug | Experimental | Drug: AK0529The participants will receive AK0529 of 10 mg, 20 mg or 40 mg based on body weight twice daily for 5 days from D1 to D5. |
| Placebo | Placebo comparator | Drug: PlaceboThe participants will receive placebo of 10 mg, 20 mg or 40 mg based on body weight twice daily for 5 days from D1 to D5. |
Who may qualify
- Ages
- 1 month to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AK0529Active Substance: AK0529, Pharmaceutical Form: Enteric pellets, Route of Administration: Oral | Drug | Active drug |
| PlaceboActive Substance: Placebo, Pharmaceutical Form: Enteric pellets, Route of Administration: Oral | Drug | Placebo |
Primary outcome
Change from baseline in the Wang bronchiolitis clinical score
Time frame: Day 3 (48 hours)
The Wang bronchiolitis clinical score will be used to evaluate respiratory rate, wheezing, respiratory muscle retraction and "general condition" (sleep, feeding, and general status) in subjects with symptoms of bronchiolitis. Each item of the scale is divided into 4 levels according to the severity of symptoms, with 0 point indicating normal and 3 points the highest severity, 12 points in total.
9 secondary outcomes
Change from baseline in the Wang bronchiolitis clinical score in subjects younger than 6 months.
Time frame: Day 3 (48 hours)
Time from first treatment to sustained remission of symptoms during the treatment period.
Time frame: Study period (up to 14 days)
Change in RSV VL (viral load) from baseline at each visit.
Time frame: Day 2, Day 3, Day 4, Day 5, Day 6, Day 14
Proportion of subjects with RSV VL below the lower limit of quantitation (LLOQ) at each visit.
Time frame: Day 2, Day 3, Day 4, Day 5, Day 6, Day 14
Time from first treatment to mild disease for subjects, defined as achieving a Wang bronchiolitis clinical score ≤ 3 without the need for supplemental oxygen.
Time frame: Study period (up to 14 days)
Change in sub-scores of the Wang bronchiolitis clinical score from baseline at each visit.
Time frame: Day 2, Day 3, Day 4, Day 5, Day 6, Day 14
Time from initial dosing to resolution of symptoms based on sub-scores of the Wang bronchiolitis clinical score.
Time frame: Study period (up to 14 days)
Safety endpoints
Time frame: Study period (up to 14 days)
Pharmacokinetic endpoints
Time frame: Study period (up to 14 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Respiratory Synctial Virus Infections
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Respiratory Synctial Virus Infections
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AK0529 in people with Respiratory Synctial Virus Infections, run by Shanghai Ark Biopharmaceutical Co., Ltd. at 17 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 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Change from baseline in the Wang bronchiolitis clinical score (time frame: Day 3 (48 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.