Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04788017
Status:
COMPLETED
Last Update Posted:
2022-02-15
First Post:
2021-02-01
Brief Title:
A Study Evaluating the Safety Tolerability and Pharmacokinetics of Ziresovir in Healthy Subjects
Sponsor:
Shanghai Ark Biopharmaceutical Co Ltd
Organization:
Shanghai Ark Biopharmaceutical Co Ltd
Study Overview
Official Title:
A Phase 1 Randomized Double-Blind Placebo-Controlled Sequential Parallel Group Single Ascending Dose Study Evaluating the Safety Tolerability and Pharmacokinetics of Ziresovir in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a randomized double-blind placebo-controlled dose escalation study to evaluate the safety tolerability and pharmacokinetics PK of ziresovir following a single ascending oral dose administration in healthy adult subjects under fasted conditions
Detailed Description:
Up to 3 dose cohorts are planned The ziresovir dose level of each cohort is determined based on the collective clinical and nonclinical data of ziresovir
The proposed dose levels of Cohorts 1 2 and 3 are 300 mg and up to 600 mg and up to 900 mg respectively
A total of up to 24 subjects will be randomized with 18 subjects to receive active drug and 6 subjects to receive placebo in a double-blind fashion Eight subjects will be randomized in each dose cohort with 6 subjects to receive active drug and 2 subjects o receive placebo
The proposed dose levels of Cohorts 1 2 and 3 are 300 mg and up to 600 mg and up to 900 mg respectively
A total of up to 24 subjects will be randomized with 18 subjects to receive active drug and 6 subjects to receive placebo in a double-blind fashion Eight subjects will be randomized in each dose cohort with 6 subjects to receive active drug and 2 subjects o receive placebo
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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