Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06308861
Status:
COMPLETED
Last Update Posted:
2024-03-13
First Post:
2024-03-05
Brief Title:
Phase 1 Study to Investigate Safety Tolerability PKPK of J2H-1702 in Healthy Males
Sponsor:
J2H Biotech
Organization:
J2H Biotech
Study Overview
Official Title:
A Dose Block-randomized Double-blind Placebo Controlled Single and Multiple-dosing Dose-escalation Phase 1 Clinical Trial to Investigate the Safety Tolerability PKPD of J2H-1702 After Oral Administration in Healthy Male Subjects
Status:
COMPLETED
Status Verified Date:
2024-03
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:
1 Research Purpose To evaluate the safety tolerability pharmacokineticpharmacodynamic properties of J2H-1702 a candidate for treatment of non-alcoholic steatohepatitis in healthy men
2 Design A dose block-randomized double-blind placebo controlled single- and multiple dosing dose-escalation phase 1 clinical trial
2 Design A dose block-randomized double-blind placebo controlled single- and multiple dosing dose-escalation phase 1 clinical trial
Detailed Description:
Subjects in all dose groups will be randomized to the study group J2H-1702 group and the control group Placebo group in a 82 ratio Adverse event AE collection physical examination vital signs ECG clinical laboratory tests etc will be performed to assess the safety and tolerability and blood and urine sampling will be performed to assess the PKPD characteristics In addition blood sampling for mass cytometry multiple administration study and baseline fibroscan will be performed for the exploratory evaluation
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