Ignite Creation Date:
2025-12-24 @ 12:22 PM
Ignite Modification Date:
2025-12-28 @ 2:48 PM
Study NCT ID:
NCT06308861
Status:
COMPLETED
Last Update Posted:
2025-12-17
First Post:
2024-03-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigate Safety, Tolerability, PK/PK of J2H 1702 in Healthy Males
Sponsor:
J2H Biotech
Organization:
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, PK/PD of J2H-1702 After Oral Administration in Healthy Male Subjects
Status:
COMPLETED
Status Verified Date:
2025-02
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, pharmacokinetic/pharmacodynamic 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 8:2 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 PK/PD 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:
False
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?: