RSV InfectionPhase 1/2NCT05779995
A Study To Evaluate the Safety of XW001 Inhalation in Children With RSV
A Phase 1/2 study testing XW001 in people with RSV Infection, run by Hangzhou Sciwind Biosciences Co., Ltd. at 1 site in China.
Trial summary
This is a randomized, double-blind, placebo-controlled Phase Ib/IIa study to evaluate the safety, tolerability, efficacy, pharmacokinetics, and immunogenicity of XW001 inhalation in children with RSV infection in China Read more about this study
- Who is it for?
- Ages 1 month to 24 months
- Conditions the study is for
- RSV Infection
- What is being tested?
- XW001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2023to 8 Jan 2024
- Phase
- Phase 1/2
- 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 1 month to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female, 1 to 24 months (inclusive) at screening;
- Weight: 3-20 kg, inclusive;
- Positive RSV test within 36 hours before randomization;
- Symptomatic at screening and randomization, and the onset of RSV symptoms is within 5 days prior to the first dose of XW001;
- Parents/legal guardians are able to understand the purpose and procedures of the study, and are able to provide informed consent.
Who cannot join
- Immunocompromised as determined by the investigator;
- Known to have undergone or planned for bone marrow, stem cells, or other organ transplants, or are currently on immunosuppressive treatment;
- Positive for HBV, HCV or HIV, or patient <6 months old whose mother is positive for HIV;
- History of seizures or epilepsy, including febrile seizure;
- Known to have received any prohibited medications defined by the protocol within 3 days prior to randomization;
- History of any surgery within 30 days prior to randomization;
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- Severe dental or facial deformity that will impact on usage of nebulizer;
- History of receiving measles, mumps, rubella or other vaccines within 7 days prior to screening;
- Known to have received any investigational medicinal products or devices in the past 30 days;
- Any other underlying conditions that make the patient unlikely to complete the study in the opinion of the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
West China Second University Hospital, Sichuan University
Chengdu, Sichuan
About this study
Official title: Randomized, Double-blind, Placebo-controlled Phase Ib/Ⅱa Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of XW001 Inhalation in Children With Respiratory Syncytial Virus (RSV) Infection in China
This is a randomized, double-blind, placebo-controlled Phase Ib/IIa study to evaluate the safety, tolerability, efficacy, pharmacokinetics, and immunogenicity of XW001 inhalation in children with RSV infection in China
Read the detailed description
In this study, eligible participants will be randomized in a 4:1 ratio to receive XW001 inhalation (one of three dosage groups) or placebo once a day for 7 days.
- Conditions
- RSV Infection
- Being tested
- XW001, Placebo
- Keywords
- XW001, Respiratory Syncytial Virus
- 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.
XW001Drug
Inhalation solution
PlaceboDrug
Inhalation solution with matched volume
| Study group | Role | What they receive |
|---|---|---|
| C1-XW001 | Experimental | Low dose of XW001 once daily Receives: Drug: XW001 |
| C1-Placebo | Placebo comparator | Matched Placebo once daily Receives: Drug: Placebo |
| C2-XW001 | Experimental | Medium dose of XW001 once daily Receives: Drug: XW001 |
| C2-Placebo | Placebo comparator | Matched Placebo once daily Receives: Drug: Placebo |
| C3-XW001 | Experimental | High dose of XW001 once daily Receives: Drug: XW001 |
| C3-Placebo | Placebo comparator | Matched Placebo once daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events after receiving XW001
Measured: Day 1 to Day 28
Secondary outcomes (4)
Change from baseline in RSV load via nasopharyngeal swab
Measured: Baseline, Day 2 to Day 8
Change from baseline in Wang Respiratory Score
Measured: Baseline, Day 2 to Day 8
Pharmacokinetics-Plasma level of XW001
Measured: Baseline, Day 8
Immunogenicity-Anti-drug Antibody of XW001
Measured: Baseline, Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start20 Apr 2023
- Primary completion10 Oct 2023
- Study completion8 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RSV InfectionStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hangzhou Sciwind Biosciences Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hanmin Liu, Dr, Principal investigator, West China Second University HospitalQin Yu, Principal investigator, West China Second University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05779995
- Sponsor's protocol ID
- SCW1201-3021
- Status last verified
- Jul 2023
- First submitted
- 6 Feb 2023
- Last updated
- 17 Aug 2025
- 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 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled Phase Ib/Ⅱa Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of XW001 Inhalation in Children With Respiratory Syncytial Virus (RSV) Infection in China
- ClinicalTrials.gov ID
- NCT05779995
- Acronym / sponsor ID
- SCW1201-3021
- Conditions
- RSV Infection
- Keywords
- XW001, Respiratory Syncytial Virus
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Hangzhou Sciwind Biosciences Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- 10 Oct 2023 (actual)
- Study completion
- 8 Jan 2024 (actual)
- First posted
- 22 Mar 2023 (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.
This is a randomized, double-blind, placebo-controlled Phase Ib/IIa study to evaluate the safety, tolerability, efficacy, pharmacokinetics, and immunogenicity of XW001 inhalation in children with RSV infection in China
Detailed description
In this study, eligible participants will be randomized in a 4:1 ratio to receive XW001 inhalation (one of three dosage groups) or placebo once a day for 7 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| C1-XW001 | Experimental | Drug: XW001Low dose of XW001 once daily |
| C1-Placebo | Placebo comparator | Drug: PlaceboMatched Placebo once daily |
| C2-XW001 | Experimental | Drug: XW001Medium dose of XW001 once daily |
| C2-Placebo | Placebo comparator | Drug: PlaceboMatched Placebo once daily |
| C3-XW001 | Experimental | Drug: XW001High dose of XW001 once daily |
| C3-Placebo | Placebo comparator | Drug: PlaceboMatched Placebo once daily |
Who may qualify
- Ages
- 1 month to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Male or female, 1 to 24 months (inclusive) at screening;
- Weight: 3-20 kg, inclusive;
- Positive RSV test within 36 hours before randomization;
- Symptomatic at screening and randomization, and the onset of RSV symptoms is within 5 days prior to the first dose of XW001;
- Parents/legal guardians are able to understand the purpose and procedures of the study, and are able to provide informed consent.
Key exclusion criteria (10 listed)
- Immunocompromised as determined by the investigator;
- Known to have undergone or planned for bone marrow, stem cells, or other organ transplants, or are currently on immunosuppressive treatment;
- Positive for HBV, HCV or HIV, or patient <6 months old whose mother is positive for HIV;
- History of seizures or epilepsy, including febrile seizure;
- Known to have received any prohibited medications defined by the protocol within 3 days prior to randomization;
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 |
|---|---|---|
| XW001Inhalation solution | Drug | C1-XW001, C2-XW001, C3-XW001 |
| PlaceboInhalation solution with matched volume | Drug | C1-Placebo, C2-Placebo, C3-Placebo |
Primary outcome
Incidence of Adverse Events after receiving XW001
Time frame: Day 1 to Day 28
4 secondary outcomes
Change from baseline in RSV load via nasopharyngeal swab
Time frame: Baseline, Day 2 to Day 8
Change from baseline in Wang Respiratory Score
Time frame: Baseline, Day 2 to Day 8
Pharmacokinetics-Plasma level of XW001
Time frame: Baseline, Day 8
Immunogenicity-Anti-drug Antibody of XW001
Time frame: Baseline, Day 28
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 17 Aug 2025.
- Individual participant dataSharing planned: No
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RSV
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.
Hanmin Liu, Dr principal investigator
West China Second University Hospital
Qin Yu principal investigator
West China Second University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing XW001 in people with RSV Infection, run by Hangzhou Sciwind Biosciences Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. 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 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 of Adverse Events after receiving XW001 (time frame: Day 1 to Day 28). 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 17 Aug 2025.