Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06308874
Status:
COMPLETED
Last Update Posted:
2024-03-13
First Post:
2024-03-05
Brief Title:
Phase 1 Study to Investigate Safety Tolerability PKPD of J2H-1702 in Healthy Females
Sponsor:
J2H Biotech
Organization:
J2H Biotech
Study Overview
Official Title:
A Double-Blind Placebo Controlled Single Dosing Dose-Escalation Phase 1 Clinical Trial to Investigate the Safety Tolerability PharmacokineticsPharmacodynamics Characteristics of J2H-1702 After Oral Administration in Healthy Female 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:
- Objectives Primary objective_To evaluate the safety and tolerability after single oral administration of the investigational product IP J2H-1702 in healthy female subjects Secondary objective_To evaluate the pharmacokinetics PK and pharmacodynamics PD characteristics after single oral administration of the IP J2H-1702 in healthy female subjects
Detailed Description:
- Study Methodology 6 Subjects will be randomized to the study group J2H-1702 group and 2 subjects will be to the placebo group AE VS ECG Lab tests will be evaluated to check the safety tolerability and PKPD
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