A Study of XW001 in Healthy Adult Subjects

NCT05642403 | Completed Phase 1

• 1 other identifier: SCW1201-3011
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Respiratory Syncytial Virus Infections

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

SAD Cohort A XW001

ACTIVE COMPARATOR

Single inhalation of XW001

Drug: XW001

SAD Cohort A placebo

PLACEBO COMPARATOR

Single inhalation of placebo

Drug: Placebo

MAD Cohort B XW001

ACTIVE COMPARATOR

Multiple inhalations of XW001

Drug: XW001

MAD Cohort B placebo

PLACEBO COMPARATOR

Multiple inhalations of placebo

Drug: Placebo

Interventions

XW001 DRUG

Inhaled XW001

Also known as: XW001 Inhalational solution

MAD Cohort B XW001; SAD Cohort A XW001

Placebo DRUG

Matched inhaled placebo

Also known as: Matched placebo Inhalational solution

MAD Cohort B placebo; SAD Cohort A placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Hangzhou Sciwind Biosciences Co., Ltd.: lead

Study Sites (1)

The Third Hospital of Changsha

Changsha, Hunan, 410035, China

Location

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Interventions

XW001

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Xin Li

  The Third Hospital of Changsha

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: December 8, 2022
• Study Start: January 3, 2021
• Primary Completion: June 20, 2022
• Study Completion: June 20, 2022
• Last Updated: March 8, 2023

Record last verified: 2022-11

Locations

CN (1)