NCT05642403

A 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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Hangzhou Sciwind Biosciences Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	XW001	Inhaled XW001
DRUG	Placebo	Matched inhaled placebo

Timeline

• Start date: 2021-01-03
• Primary completion: 2022-06-20
• Completion: 2022-06-20
• First posted: 2022-12-08
• Last updated: 2023-03-08

Locations

1 site across 1 country: China