Ignite Creation Date:
2025-12-25 @ 12:55 AM
Ignite Modification Date:
2026-02-27 @ 10:37 AM
Study NCT ID:
NCT02668367
Status:
COMPLETED
Last Update Posted:
2018-05-30
First Post:
2016-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Pharmacokinetics Study of Multiple Ascending Doses of BTA-C585 in Healthy Volunteers
Sponsor:
Biota Pharmaceuticals, Inc.
Organization:
Study Overview
Official Title:
A Sequential-Cohort, Double-Blind, Placebo-Controlled, Multiple Ascending Oral Dose Study of the Safety and Pharmacokinetics of BTA-C585 in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2018-05
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 single center, sequential-cohort, double-blind, placebo-controlled, multiple ascending dose (MAD), 7-day treatment period study in healthy subjects.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: