Ignite Creation Date:
2024-05-06 @ 2:58 PM
Last Modification Date:
2024-10-26 @ 1:40 PM
Study NCT ID:
NCT04480697
Status:
COMPLETED
Last Update Posted:
2022-04-25
First Post:
2020-07-14
Brief Title:
Study of Safety Tolerability and PK PD of HPG1860 in Healthy Subjects
Sponsor:
Hepagene Shanghai Co Ltd
Organization:
Hepagene Shanghai Co Ltd
Study Overview
Official Title:
A Randomized Double-Blind Placebo Controlled Single and Multiple Ascending Doses SADMAD Study Following Oral Administration in Healthy Subjects to Evaluate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of HPG1860
Status:
COMPLETED
Status Verified Date:
2022-04
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 randomized double-blind placebo-controlled single and multiple ascending dose Phase 1study to evaluate the safety tolerability pharmacokinetics pharmacodynamics and food effect of HPG1860 orally administered in healthy subjects
Detailed Description:
In SAD and MAD studies all subjects are randomized in a 31 ratio In SAD study there are 6 cohorts 8 subjectscohort with dose levels of 10mg 20 mg 40 mg 80 mg 120 mg and 150 mg respectively Blood samples will be collected for safety PK and PD assessments After the completion of Cohort 2 20 mg in SAD study following a 7-day washout period the same 8 subjects will receive another single oral dose of 20 mg HPG1860 after a standard high fathigh calorie breakfast the fed condition PK blood samplings will be collected and Cmax and AUC will be used for assessing the food effect In MAD study there are 3 cohorts 8 subjectscohort with dose levels of 10mg 30mg and 90 mg respectively and dosing regimen is once daily for 14 consecutive days Blood samples will be collected for safety PK and PD assessments
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