Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06627556
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-03
Brief Title:
A Study of Single and Multiple Ascending Doses of H021 in Healthy Participants
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1 Randomized Double-Blind Placebo-Controlled Study to Evaluate the Safety Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of H021 in Healthy Participants
Status:
RECRUITING
Status Verified Date:
2024-09
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:
The primary purpose of this study is to evaluate the safety and tolerability of H021 tablets following oral administration of single and multiple ascending doses in healthy participants
Detailed Description:
This is a single center Phase 1 randomized double-blind placebo controlled sequential single ascending dosemultiple ascending dose SADMAD study with a food-effect arm The study will be divided into two parts
SAD cohorts with food-effect evaluation
MAD cohorts The two parts will be completed sequentially but with partial overlapping The MAD phase can start once safety tolerability and pharmacokinetic data from the SAD phase show that single doses of at least 25 mg are acceptable If the 25 mg dose will be not reached in the SAD phase the Safety Review Committee SRC will set a new starting dose
SAD cohorts with food-effect evaluation
MAD cohorts The two parts will be completed sequentially but with partial overlapping The MAD phase can start once safety tolerability and pharmacokinetic data from the SAD phase show that single doses of at least 25 mg are acceptable If the 25 mg dose will be not reached in the SAD phase the Safety Review Committee SRC will set a new starting dose
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?:
None