Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-26 @ 1:35 AM
Study NCT ID:
NCT07301333
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-24
First Post:
2025-12-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Single and Multiple Doses of HRS-6257 in Healthy Subjects
Sponsor:
Shanghai Hengrui Pharmaceutical Co., Ltd.
Organization:
Study Overview
Official Title:
A Phase 1 Study To Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and the Effect of Food on the Bioavailability of HRS-6257 in Healthy Subjects
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-11
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, randomised, single-blind placebo-controlled, 2-part study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of single and multiple oral doses of HRS-6257 in healthy volunteers.
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?: