Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06393803
Status:
RECRUITING
Last Update Posted:
2024-05-07
First Post:
2024-01-04
Brief Title:
Phase 1 Study of KH607 Tablets
Sponsor:
Chengdu Kanghong Pharmaceutical Group Co Ltd
Organization:
Chengdu Kanghong Pharmaceutical Group Co Ltd
Study Overview
Official Title:
A Phase 1 Study to Evaluate the Safety Tolerability and Pharmacokinetic Profile of Single and Multiple Doses of KH607 Tablets in Chinese Healthy Volunteers
Status:
RECRUITING
Status Verified Date:
2024-05
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 study was a single-center randomized double-blind placebo-controlled study divided into a Single Ascending Dose SAD stage and a Multiple Ascending Dose MAD stage The primary objective was to evaluate the safety and tolerability of KH607 tablets in Chinese healthy volunteers
Detailed Description:
This study consists of two parts Part 1-SAD phase and Part 2- MAD phase There will be eight cohorts in Part 1 and three cohorts in Part 2 of this study
The SAD study will enroll approximately 58 HVs across 8 dose cohorts The dose cohorts will include the following dose levels 2 mg 5 mg 10 mg 20 mg 30 mg 40 mg 50mg and 60 mg All participants in Part 1 will be administered with a single oral dose of KH607 or its matching placebo under fasted condition
Approximately 30 HVs will be enrolled in the multiple ascending dose study The dose cohorts will include the following dose levels 10 mg 20 mg 30 mgAt each cohort 10 subjects will be randomized in a ratio of 82 to be receive KH607 or placebo once daily for continuous 7 days QDx7d in a double-blind manner
Additionally this study will explore the effect of food on the PK of a single oral administration of KH607 in one selected SAD cohort
The SAD study will enroll approximately 58 HVs across 8 dose cohorts The dose cohorts will include the following dose levels 2 mg 5 mg 10 mg 20 mg 30 mg 40 mg 50mg and 60 mg All participants in Part 1 will be administered with a single oral dose of KH607 or its matching placebo under fasted condition
Approximately 30 HVs will be enrolled in the multiple ascending dose study The dose cohorts will include the following dose levels 10 mg 20 mg 30 mgAt each cohort 10 subjects will be randomized in a ratio of 82 to be receive KH607 or placebo once daily for continuous 7 days QDx7d in a double-blind manner
Additionally this study will explore the effect of food on the PK of a single oral administration of KH607 in one selected SAD cohort
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