Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06350279
Status:
RECRUITING
Last Update Posted:
2024-04-05
First Post:
2024-04-01
Brief Title:
A Phase I Study to Assess the SafetyTolerability PK PD and Food Effect of HSK39297 in Healthy Subjects
Sponsor:
Haisco Pharmaceutical Group Co Ltd
Organization:
Haisco Pharmaceutical Group Co Ltd
Study Overview
Official Title:
A Single and Multiple Ascending Dose Study to Assess the SafetyTolerability PK PD and Food Effect of HSK39297 in Healthy Subjects
Status:
RECRUITING
Status Verified Date:
2024-04
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 I randomized subject-blinded placebo controlled study to assess the safety tolerability pharmacokinetic PK pharmacodynamic PDand food effect FE of HSK39297 following 1 a single ascending dose part 1 2 10 days of multiple ascending dose part 2 and 3 a single dose two-period crossover FE cohort
Detailed Description:
None
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