Ignite Creation Date:
2024-05-06 @ 7:15 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05946876
Status:
RECRUITING
Last Update Posted:
2024-01-18
First Post:
2023-07-07
Brief Title:
A Phase 1 Study of XH-S003 in Healthy Volunteers
Sponsor:
S-Infinity Pharmaceuticals Co Ltd
Organization:
S-Infinity Pharmaceuticals Co Ltd
Study Overview
Official Title:
A Phase I Study to Assess the Safety Tolerability Pharmacokinetics of XH-S003 After Single and Multiple Ascending Doses Plus the Evaluation of Food Effects in Healthy Volunteers
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:
This is a phase 1 randomised first-in-human double-blinded placebo-controlled SAD Single Ascending Dose and MAD Multiple Ascending Dose study to assess the PK safety and tolerability of XH-S003 in healthy volunteers In addition this study evaluates the effects of food on XH-S003 under a two-period cross-over study setting
Detailed Description:
The study is composed of three parts Part A SAD portion 5 cohorts and Part B MAD portion 3 cohorts of the study will enrol eligible participants and provide various doses of XH-S003 or placebo at a ratio of 31 in each cohort Part C of the study plans to evaluate the food effect on XH-S003
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