Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is the first-in-human, single-center, randomized, double-blinded, placebocontrolled, single-dose and multiple-dose escalation Phase Ia study
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAD Cohort A XW001 | Active Comparator | Single inhalation of XW001 |
|
| SAD Cohort A placebo | Placebo Comparator | Single inhalation of placebo |
|
| MAD Cohort B XW001 | Active Comparator | Multiple inhalations of XW001 |
|
| MAD Cohort B placebo | Placebo Comparator | Multiple inhalations of placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XW001 | Drug | Inhaled XW001 |
|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Xin Li | The Third Hospital of Changsha | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Hospital of Changsha | Changsha | Hunan | 410035 | China |
Not provided
| ID | Term |
|---|---|
| D018357 | Respiratory Syncytial Virus Infections |
| ID | Term |
|---|---|
| D018186 | Pneumovirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C000719812 | XW001 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Matched inhaled placebo |
|
|
| D014777 | Virus Diseases |
| D007239 | Infections |