Ignite Creation Date:
2024-05-06 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06204250
Status:
RECRUITING
Last Update Posted:
2024-03-25
First Post:
2024-01-03
Brief Title:
A Study to Assess Safety and Tolerability of GS1-144 in Healthy Volunteers
Sponsor:
Changchun GeneScience Pharmaceutical Co Ltd
Organization:
Changchun GeneScience Pharmaceutical Co Ltd
Study Overview
Official Title:
A Phase 1 Clinical Study to Assess the Safety Tolerability Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Doses of GS1-144 Tablets
Status:
RECRUITING
Status Verified Date:
2024-01
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:
The primary purpose of this study is to assess the safety and tolerability of single ascending doses of GS1-144 in healthy participants in Part 1 and to assess the safety and tolerability of multiple ascending doses of GS1-144 in healthy postmenopausal female participants in Part 2
Detailed Description:
This study will be divided into two sequential parts Part 1 single ascending dose SAD and Part 2 multiple ascending dose MAD with the overall design
Part 1 will enroll a total of approximately 38 healthy participants in five cohorts at 5 milligram mg 15 mg 30 mg 60 mg and 90 mg dose levels Each cohort will have 2 participants receiving placebo There is no restriction on the male-to female ratio
Part 2 will be conducted after confirming the safety and tolerability of the -30mg dose in Part 1 and will enroll a total of approximately 30 healthy postmenopausal female participants and provisionally consists of three cohorts at 15 mg 30 mg and 60 mg dose levels Each cohort will have 2 participants receiving placebo
Part 1 will enroll a total of approximately 38 healthy participants in five cohorts at 5 milligram mg 15 mg 30 mg 60 mg and 90 mg dose levels Each cohort will have 2 participants receiving placebo There is no restriction on the male-to female ratio
Part 2 will be conducted after confirming the safety and tolerability of the -30mg dose in Part 1 and will enroll a total of approximately 30 healthy postmenopausal female participants and provisionally consists of three cohorts at 15 mg 30 mg and 60 mg dose levels Each cohort will have 2 participants receiving placebo
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