A Study of XW001 in Healthy Adult Subjects

NCT ID: NCT05642403

Last Updated: 2023-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-03
• Study Completion Date: 2022-06-20

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.

Conditions

Respiratory Syncytial Virus Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

SAD Cohort A XW001

Single inhalation of XW001

Group Type: ACTIVE_COMPARATOR

XW001

Intervention Type: DRUG

Inhaled XW001

SAD Cohort A placebo

Single inhalation of placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matched inhaled placebo

MAD Cohort B XW001

Multiple inhalations of XW001

Group Type: ACTIVE_COMPARATOR

XW001

Intervention Type: DRUG

Inhaled XW001

MAD Cohort B placebo

Multiple inhalations of placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matched inhaled placebo

Interventions

XW001

Inhaled XW001

Intervention Type: DRUG

Placebo

Matched inhaled placebo

Intervention Type: DRUG

Other Intervention Names

XW001 Inhalational solution; Matched placebo Inhalational solution

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hangzhou Sciwind Biosciences Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xin Li

Role: PRINCIPAL_INVESTIGATOR

The Third Hospital of Changsha

Locations

The Third Hospital of Changsha

Changsha, Hunan, China

Countries

China

Other Identifiers

SCW1201-3011

Identifier Type: -

Identifier Source: org_study_id