Ignite Creation Date:
2024-05-06 @ 3:16 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04576312
Status:
COMPLETED
Last Update Posted:
2021-08-26
First Post:
2020-09-28
Brief Title:
Safety of Ascending Doses of Niclosamide UNI911 INHALATION in Healthy Volunteers
Sponsor:
UNION therapeutics
Organization:
UNION therapeutics
Study Overview
Official Title:
Phase 1 Randomized Double-Blind Parallel Group Placebo-Controlled Study to Assess the Safety of Ascending Doses of UNI911 INHALATION in Healthy Volunteers in Preparation for Evaluation in Adults With COVID-19
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase 1 Randomized Double-Blind Parallel Group Placebo-Controlled Study to Assess the Safety of Ascending Doses of UNI911 INHALATION in Healthy Volunteers in Preparation for Evaluation in Adults with COVID-19
Detailed Description:
This is a Phase 1 Randomized Double-Blind Parallel Group Placebo-Controlled Study to Assess the Safety of Ascending Doses of UNI911 INHALATION in Healthy Volunteers in Preparation for Evaluation in Adults with COVID-19
64 subjects will be sequentially enrolled to receive dosage of UNI911 INHALATION or placebo 4 sentinel subjects one per cohort 1 2 3 and 4 will be treated in an open-label manner to confirm the safety of each dose sequentially 40 subjects will be randomly assigned 31 to either active or placebo For the last 2 cohorts a total of 20 healthy volunteers will be enrolled to receive multiple doses of UNI911 INHALATION
64 subjects will be sequentially enrolled to receive dosage of UNI911 INHALATION or placebo 4 sentinel subjects one per cohort 1 2 3 and 4 will be treated in an open-label manner to confirm the safety of each dose sequentially 40 subjects will be randomly assigned 31 to either active or placebo For the last 2 cohorts a total of 20 healthy volunteers will be enrolled to receive multiple doses of UNI911 INHALATION
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-002049-40 | EUDRACT_NUMBER | None | None |