Ignite Creation Date:
2025-12-18 @ 9:46 AM
Ignite Modification Date:
2025-12-23 @ 9:48 PM
Study NCT ID:
NCT04709913
Status:
None
Last Update Posted:
2021-08-16 00:00:00
First Post:
2021-01-08 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multiple Ascending Dose Study of HU6 in High BMI Volunteers
Sponsor:
None
Organization:
Study Overview
Official Title:
A Double-blind, Sponsor-Open, Placebo-controlled, Phase I Study of the Safety, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of HU6 in High BMI Volunteers
Status:
None
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 14-day multiple ascending dose trial in high BMI volunteers in up to 4 cohorts of 10 high BMI volunteers each consisting of 8 receiving HU6 and 2 receiving placebo. Upon review of the safety and PK data, it may be decided to expand the current cohort size and/or dose escalate to the next cohort. In addition, the sponsor may elect not to enroll all 4 cohorts based on safety and/or PK and/or PD data, or enlist an additional cohort at a higher dose if deemed safe.
Double-blind dosing will occur in cohorts 1 through 4. In these cohorts, 8 subjects will receive HU6 and 2 will receive matching placebo. Doses will escalate and may be modified based on results of safety and pharmacokinetic evaluation conducted after each cohort.
Double-blind dosing will occur in cohorts 1 through 4. In these cohorts, 8 subjects will receive HU6 and 2 will receive matching placebo. Doses will escalate and may be modified based on results of safety and pharmacokinetic evaluation conducted after each cohort.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?: