A Study of XW001 in Healthy Adult Subjects

Respiratory Syncytial Virus Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05642403
• Other study ID #: SCW1201-3011
• Status: Completed
• Phase: Phase 1
• Start date: January 3, 2021
• Est. completion date: June 20, 2022

Study information

• Verified date: November 2022
• Source: Hangzhou Sciwind Biosciences Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is the first-in-human, single-center, randomized, double-blinded, placebocontrolled, single-dose and multiple-dose escalation Phase Ia study

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: June 20, 2022
• Est. primary completion date: June 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Healthy subjects aged 18-45 years (including both ends), male or female;

2. Body mass index (BMI) of 19.0-28.0 kg/m2 (including both ends);

3. 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;

4. Subjects who can communicate well with the investigators, and understand and abide by the requirements of this study.

Exclusion Criteria:

1. (Screening period) Subjects participated in any drug clinical trial or used the investigational drug within 3 months prior to the trial;

2. (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.

3. (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;

4. (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;

5. 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);

6. 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%);

7. 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.

Related Conditions & MeSH terms

• Respiratory Syncytial Virus Infections

Intervention

Drug:
• XW001
Inhaled XW001
• Placebo
Matched inhaled placebo

Locations

Country	Name	City	State
China	The Third Hospital of Changsha	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Hangzhou Sciwind Biosciences Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety/tolerance endpoints	Number and percentage of treatment emergent adverse events (TEAE) and serious adverse events (SAE)	28 Days for Cohort A and 42 Days for Cohort B