Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06633055
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-28
Brief Title:
A Phase I Clinical Trial of JH013 Injection
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase I Clinical Trial of the Safety Tolerability Pharmacokinetics and Pharmacodynamics of JH013 Injection in Healthy Subjects
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a phase I clinical trial with a single dose escalation to evaluate the safety tolerability pharmacokinetics and pharmacodynamics of JH013 injection in healthy subjects
Detailed Description:
Four dose groups were set up 75 mg 150 mg 300 mg and 500 mg respectively Eight subjects 6 subjects received JH013 injection 2 subjects received placebo were planned to be included in each dose group for subcutaneous administrationThe safety and tolerability within 48 hours after administration were first observed in each dose group with 2 subjects 1 subject receiving JH013 injection and 1 subject receiving placeboafter that the remaining 6 subjects 5 receiving JH013 injection and 1 receiving placebo were enrolled Each subject may only participate in this trial in one dose group and the next higher dose trial will only be allowed after it has been determined that the previous dose has been well safe and tolerated within 28 days of dosing as determined by an independent unblinded third-party physician in conjunction with the investigator and sponsor When the safety evaluation meets the termination criteria during the dose escalation process the dose between the dose group and the previous dose group can be returned if necessary after discussion by the investigator and the sponsor and the maximum safe tolerated dose can be explored again When the dose is escalated to the highest dose set by the protocol and the dose termination criteria are not met it is up to the investigator and the sponsor to discuss whether to expand to a higher dose
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None