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A Study To Evaluate the Safety of XW001 Inhalation in Children With RSV

Primary Purpose

RSV Infection

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
XW001
Placebo
Sponsored by
Hangzhou Sciwind Biosciences Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for RSV Infection focused on measuring XW001, Respiratory Syncytial Virus

Eligibility Criteria

1 Month - 24 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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; 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.

Sites / Locations

  • West China Second University Hospital, Sichuan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

C1-XW001

C1-Placebo

C2-XW001

C2-Placebo

C3-XW001

C3-Placebo

Arm Description

Low dose of XW001 once daily

Matched Placebo once daily

Medium dose of XW001 once daily

Matched Placebo once daily

High dose of XW001 once daily

Matched Placebo once daily

Outcomes

Primary Outcome Measures

Incidence of Adverse Events after receiving XW001

Secondary Outcome Measures

Change from baseline in RSV load via nasopharyngeal swab
Change from baseline in Wang Respiratory Score
Pharmacokinetics-Plasma level of XW001
Immunogenicity-Anti-drug Antibody of XW001

Full Information

First Posted
February 6, 2023
Last Updated
July 13, 2023
Sponsor
Hangzhou Sciwind Biosciences Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05779995
Brief Title
A Study To Evaluate the Safety of XW001 Inhalation in Children With RSV
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 20, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hangzhou Sciwind Biosciences Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
RSV Infection
Keywords
XW001, Respiratory Syncytial Virus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
C1-XW001
Arm Type
Experimental
Arm Description
Low dose of XW001 once daily
Arm Title
C1-Placebo
Arm Type
Placebo Comparator
Arm Description
Matched Placebo once daily
Arm Title
C2-XW001
Arm Type
Experimental
Arm Description
Medium dose of XW001 once daily
Arm Title
C2-Placebo
Arm Type
Placebo Comparator
Arm Description
Matched Placebo once daily
Arm Title
C3-XW001
Arm Type
Experimental
Arm Description
High dose of XW001 once daily
Arm Title
C3-Placebo
Arm Type
Placebo Comparator
Arm Description
Matched Placebo once daily
Intervention Type
Drug
Intervention Name(s)
XW001
Intervention Description
Inhalation solution
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Inhalation solution with matched volume
Primary Outcome Measure Information:
Title
Incidence of Adverse Events after receiving XW001
Time Frame
Day 1 to Day 28
Secondary Outcome Measure Information:
Title
Change from baseline in RSV load via nasopharyngeal swab
Time Frame
Baseline, Day 2 to Day 8
Title
Change from baseline in Wang Respiratory Score
Time Frame
Baseline, Day 2 to Day 8
Title
Pharmacokinetics-Plasma level of XW001
Time Frame
Baseline, Day 8
Title
Immunogenicity-Anti-drug Antibody of XW001
Time Frame
Baseline, Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lei Guan
Phone
+86-18910900897
Email
lei.guan@sciwindbio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanmin Liu, Dr
Organizational Affiliation
West China Second University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Qin Yu
Organizational Affiliation
West China Second University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
West China Second University Hospital, Sichuan University
City
Chengdu
State/Province
Sichuan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanmin Liu, Dr
Phone
02885503960
First Name & Middle Initial & Last Name & Degree
Qin Yu, Dr
Phone
02885503960

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study To Evaluate the Safety of XW001 Inhalation in Children With RSV

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