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A Study of XW001 in Healthy Adult Subjects

Primary Purpose

Respiratory Syncytial Virus Infections

Status
Completed
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 Respiratory Syncytial Virus Infections

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. Exclusion Criteria: (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.

Sites / Locations

  • The Third Hospital of Changsha

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

SAD Cohort A XW001

SAD Cohort A placebo

MAD Cohort B XW001

MAD Cohort B placebo

Arm Description

Single inhalation of XW001

Single inhalation of placebo

Multiple inhalations of XW001

Multiple inhalations of placebo

Outcomes

Primary Outcome Measures

Safety/tolerance endpoints
Number and percentage of treatment emergent adverse events (TEAE) and serious adverse events (SAE)

Secondary Outcome Measures

Full Information

First Posted
November 30, 2022
Last Updated
March 6, 2023
Sponsor
Hangzhou Sciwind Biosciences Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05642403
Brief Title
A Study of XW001 in Healthy Adult Subjects
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 3, 2021 (Actual)
Primary Completion Date
June 20, 2022 (Actual)
Study Completion Date
June 20, 2022 (Actual)

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Syncytial Virus Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SAD Cohort A XW001
Arm Type
Active Comparator
Arm Description
Single inhalation of XW001
Arm Title
SAD Cohort A placebo
Arm Type
Placebo Comparator
Arm Description
Single inhalation of placebo
Arm Title
MAD Cohort B XW001
Arm Type
Active Comparator
Arm Description
Multiple inhalations of XW001
Arm Title
MAD Cohort B placebo
Arm Type
Placebo Comparator
Arm Description
Multiple inhalations of placebo
Intervention Type
Drug
Intervention Name(s)
XW001
Other Intervention Name(s)
XW001 Inhalational solution
Intervention Description
Inhaled XW001
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Matched placebo Inhalational solution
Intervention Description
Matched inhaled placebo
Primary Outcome Measure Information:
Title
Safety/tolerance endpoints
Description
Number and percentage of treatment emergent adverse events (TEAE) and serious adverse events (SAE)
Time Frame
28 Days for Cohort A and 42 Days for Cohort B

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: (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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xin Li
Organizational Affiliation
The Third Hospital of Changsha
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Third Hospital of Changsha
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410035
Country
China

12. IPD Sharing Statement

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A Study of XW001 in Healthy Adult Subjects

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