Respiratory Syncytial Virus InfectionsPhase 1NCT05642403
A Study of XW001 in Healthy Adult Subjects
A Phase 1 study testing XW001 in people with Respiratory Syncytial Virus Infections, run by Hangzhou Sciwind Biosciences Co., Ltd. at 1 site in China.
Trial summary
This is the first-in-human, single-center, randomized, double-blinded, placebocontrolled, single-dose and multiple-dose escalation Phase Ia study Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus Infections
- What is being tested?
- XW001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteChina
- Study dates
- 3 Jan 2021to 20 Jun 2022
- Phase
- Phase 1
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects aged 18-45 years (including both ends), male or female;
- Body mass index (BMI) of 19.0-28.0 kg/m2 (including both ends);
- Subjects who fully understand the trial objectives, have a basic understanding of the pharmacological effects and possible risks of the investigational drug, and voluntarily sign an informed consent form;
- Subjects who can communicate well with the investigators, and understand and abide by the requirements of this study.
Who cannot join
- (Screening period) Subjects participated in any drug clinical trial or used the investigational drug within 3 months prior to the trial;
- (Screening period/admission) Subjects with a medical history of diseases in cardiovascular system, digestive system, endocrine system, urinary system, nervous system, hematological, immunological (including personal or family history of hereditary immunodeficiency), or metabolic abnormalities, etc., that are still considered as clinically significantly by the investigators.
- (Screening period) Subjects with previously diagnosed chronic obstructive pulmonary disease (COPD), asthma, or other clinically significant lung diseases, or with a medical history of acute upper and lower respiratory infection requiring intravenous injection of antimicrobial drugs or other hospitalization treatment within the past 3 months;
- (Screening period/admission) Subjects who had underwent a surgery that is considered affecting the pharmacokinetics(PK) behaviors of the drug by the investigator within 6 months prior to the trial;
- Patients with positive endogenous interleukin 29 (IL-29) level (i.e., the test result in the screening period is higher than the lower limit of quantification);
- Subjects with lung function abnormality (measured forced expiratory volume in one second #FEV1)/predicted FEV1 ≤ 80% or measured forced vital capacity (FVC)/predicted FVC ≤ 80%);
- Subjects who are unable to complete the study for other reasons or are not suitable to participate in the trial as judged by the investigators.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase Ia Dose Escalation, Randomized, Double-Blinded, and Placebo- Controlled Clinical Study of Single Dose and Multiple Doses of XW001 Inhalation Solution in Healthy Adult Subjects
This is the first-in-human, single-center, randomized, double-blinded, placebocontrolled, single-dose and multiple-dose escalation Phase Ia study
Read the detailed description
Single ascending dose (SAD), healthy participants will be randomized to receive a single inhalational dose of either XW001 or placebo in each of the planned SAD cohorts. Multiple ascending dose (MAD), healthy participants will be randomized to receive inhalational doses of XW001 or placebo in each of the planned MAD cohorts.
- Conditions
- Respiratory Syncytial Virus Infections
- Being tested
- XW001, Placebo
- 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
Also called XW001 Inhalational solution
Inhaled XW001
PlaceboDrug
Also called Matched placebo Inhalational solution
Matched inhaled placebo
| Study group | Role | What they receive |
|---|---|---|
| SAD Cohort A XW001 | Active comparator | Single inhalation of XW001 Receives: Drug: XW001 |
| SAD Cohort A placebo | Placebo comparator | Single inhalation of placebo Receives: Drug: Placebo |
| MAD Cohort B XW001 | Active comparator | Multiple inhalations of XW001 Receives: Drug: XW001 |
| MAD Cohort B placebo | Placebo comparator | Multiple inhalations of placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety/tolerance endpoints
Number and percentage of treatment emergent adverse events (TEAE) and serious adverse events (SAE)
Measured: 28 Days for Cohort A and 42 Days for Cohort B
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start3 Jan 2021
- Primary completion20 Jun 2022
- Study completion20 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hangzhou Sciwind Biosciences Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xin Li, Principal investigator, Changsha Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05642403
- Sponsor's protocol ID
- SCW1201-3011
- Status last verified
- Nov 2022
- First submitted
- 30 Nov 2022
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ia Dose Escalation, Randomized, Double-Blinded, and Placebo- Controlled Clinical Study of Single Dose and Multiple Doses of XW001 Inhalation Solution in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT05642403
- Acronym / sponsor ID
- SCW1201-3011
- Conditions
- Respiratory Syncytial Virus Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Hangzhou Sciwind Biosciences Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Jan 2021 (actual)
- Primary completion
- 20 Jun 2022 (actual)
- Study completion
- 20 Jun 2022 (actual)
- First posted
- 8 Dec 2022 (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 the first-in-human, single-center, randomized, double-blinded, placebocontrolled, single-dose and multiple-dose escalation Phase Ia study
Detailed description
Single ascending dose (SAD), healthy participants will be randomized to receive a single inhalational dose of either XW001 or placebo in each of the planned SAD cohorts. Multiple ascending dose (MAD), healthy participants will be randomized to receive inhalational doses of XW001 or placebo in each of the planned MAD cohorts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SAD Cohort A XW001 | Active comparator | Drug: XW001Single inhalation of XW001 |
| SAD Cohort A placebo | Placebo comparator | Drug: PlaceboSingle inhalation of placebo |
| MAD Cohort B XW001 | Active comparator | Drug: XW001Multiple inhalations of XW001 |
| MAD Cohort B placebo | Placebo comparator | Drug: PlaceboMultiple inhalations of placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy subjects aged 18-45 years (including both ends), male or female;
- Body mass index (BMI) of 19.0-28.0 kg/m2 (including both ends);
- Subjects who fully understand the trial objectives, have a basic understanding of the pharmacological effects and possible risks of the investigational drug, and voluntarily sign an informed consent form;
- Subjects who can communicate well with the investigators, and understand and abide by the requirements of this study.
Key exclusion criteria (7 listed)
- (Screening period) Subjects participated in any drug clinical trial or used the investigational drug within 3 months prior to the trial;
- (Screening period/admission) Subjects with a medical history of diseases in cardiovascular system, digestive system, endocrine system, urinary system, nervous system, hematological, immunological (including personal or family history of hereditary immunodeficiency), or metabolic abnormalities, etc., that are still considered as clinically significantly by the investigators.
- (Screening period) Subjects with previously diagnosed chronic obstructive pulmonary disease (COPD), asthma, or other clinically significant lung diseases, or with a medical history of acute upper and lower respiratory infection requiring intravenous injection of antimicrobial drugs or other hospitalization treatment within the past 3 months;
- (Screening period/admission) Subjects who had underwent a surgery that is considered affecting the pharmacokinetics(PK) behaviors of the drug by the investigator within 6 months prior to the trial;
- Patients with positive endogenous interleukin 29 (IL-29) level (i.e., the test result in the screening period is higher than the lower limit of quantification);
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 |
|---|---|---|
| XW001Also: XW001 Inhalational solutionInhaled XW001 | Drug | MAD Cohort B XW001, SAD Cohort A XW001 |
| PlaceboAlso: Matched placebo Inhalational solutionMatched inhaled placebo | Drug | MAD Cohort B placebo, SAD Cohort A placebo |
Primary outcome
Safety/tolerance endpoints
Time frame: 28 Days for Cohort A and 42 Days for Cohort B
Number and percentage of treatment emergent adverse events (TEAE) and serious adverse events (SAE)
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 8 Mar 2023.
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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.
Xin Li principal investigator
Changsha Third 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 study testing XW001 in people with Respiratory Syncytial Virus Infections, 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 4 inclusion and 7 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 8 Mar 2023. 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 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.
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?
Safety/tolerance endpoints (time frame: 28 Days for Cohort A and 42 Days for Cohort B). 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 8 Mar 2023.