Phase Ia Study of XW001 in Healthy Adult Subjects

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

Study Overview

• Status: Completed
• Conditions: Respiratory Syncytial Virus Infections
• Intervention / Treatment: Drug: XW001; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 81
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410035
      • The Third Hospital of Changsha

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: SAD Cohort A XW001; Single inhalation of XW001	Drug: XW001; Inhaled XW001; Other Names: XW001 Inhalational solution
PLACEBO_COMPARATOR: SAD Cohort A placebo; Single inhalation of placebo	Drug: Placebo; Matched inhaled placebo; Other Names: Matched placebo Inhalational solution
ACTIVE_COMPARATOR: MAD Cohort B XW001; Multiple inhalations of XW001	Drug: XW001; Inhaled XW001; Other Names: XW001 Inhalational solution
PLACEBO_COMPARATOR: MAD Cohort B placebo; Multiple inhalations of placebo	Drug: Placebo; Matched inhaled placebo; Other Names: Matched placebo Inhalational solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hangzhou Sciwind Biosciences Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 3, 2021
• Primary Completion (ACTUAL): June 20, 2022
• Study Completion (ACTUAL): June 20, 2022

Study Registration Dates

• First Submitted: November 30, 2022
• First Submitted That Met QC Criteria: November 30, 2022
• First Posted (ACTUAL): December 8, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Paramyxoviridae Infections; Mononegavirales Infections; Pneumovirus Infections; Respiratory Syncytial Virus Infections; Pharmaceutical Solutions
• Other Study ID Numbers: SCW1201-3011

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No