Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06361108
Status:
RECRUITING
Last Update Posted:
2024-04-11
First Post:
2024-03-19
Brief Title:
MAD Study to Assess the Safety Tolerability PKs and Efficacy of YJ001 for Spray Use in Patients With DPNP
Sponsor:
Zhejiang Hanmai Pharmaceutical Technology Co Ltd
Organization:
Zhejiang Hanmai Pharmaceutical Technology Co Ltd
Study Overview
Official Title:
A Phase I Randomized Double-Blind Placebo Controlled MAD Study to Assess the Safety Tolerability PKs and Efficacy of Topical Application of YJ001 for Spray Use in Patients With DPNP
Status:
RECRUITING
Status Verified Date:
2024-07
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 Phase I randomized double-blind and placebo controlled study is to evaluate the safety tolerability and PK and to preliminarily assess the efficacy of topically administered YJ001 in a multiple-ascending dose MAD fashion in the patients with DPNP The study will be conducted at a single study center
In this study 2 cohorts N24 12 subjects for each cohort each cohort will consist of 10 active and 2 placebo with approximately equal numbers of male and female subjects
Each subject will be administered a single dose of YJ001 as multiple sprays topically on both feet and below the ankle in the morning on Day 1 and Day 2 and will be administered as twice daily doses once in the morning and the other in the evening with an interval of 11 to 13 h from Day 3 through Day 11
In this study 2 cohorts N24 12 subjects for each cohort each cohort will consist of 10 active and 2 placebo with approximately equal numbers of male and female subjects
Each subject will be administered a single dose of YJ001 as multiple sprays topically on both feet and below the ankle in the morning on Day 1 and Day 2 and will be administered as twice daily doses once in the morning and the other in the evening with an interval of 11 to 13 h from Day 3 through Day 11
Detailed Description:
This Phase I randomized double-blind and placebo controlled study is to evaluate the safety tolerability and PK and to preliminarily assess the efficacy of topically administered YJ001 in a multiple-ascending dose MAD fashion in the patients with DPNP between ages of 18 to 80 years The study will be conducted at a single study center
In this study 2 cohorts N24 12 subjects for each cohort the doses of which are 296 mgadministration Cohort M1 and 414 mgadministration Cohort M2 are planned Each cohort will enroll approximately equal numbers of male and female subjects The administration area is set as 450 cm2 both feet Each subject will be administered a single dose of YJ001 as multiple sprays 16 spraysfoot for Cohort M1 and 12 spraysfoot for Cohort M2 topically on both feet and below the ankle in the morning on Day 1 and Day 2 and will be administered as twice daily doses once in the morning and the other in the evening with an interval of 11 to 13 h from Day 3 through Day 11
Each cohort will consist of 12 subjects 10 active 2 placebo with approximately equal numbers of male and female subjects
Each cohort will be evaluated separately for safety and PK to allow for dose escalation based on stopping criteria per protocol The Safety Review Committee SRC comprised of the Principal Investigator Medical Monitor and Sponsors qualified designee will convene after completion of each cohort to evaluate available safety PK and other relevant data The decision whether to escalate the dose will be made for a completed cohort based on available safety data through Day 17 5 days post the last dose and blinded PK data maximum observed plasma concentration Cmaxss and area under the concentration-time curve through the first 48 hours post the last dose AUC0-48hss The SRC will determine whether to proceed to the next planned dose level continue with the study and add additional safety evaluations expand the number of subjects at the current level reduce the dose or stop the study
Subjects will be screened between Day -28 through Day -7 rate the scores on Numeric Rating Scale NRS twice daily once in the morning and the other in the evening from Day -7 to Day -1 and will be admitted to the clinic on Day-1 Subjects will be housed within the clinic from Day -1 through Day 17 and will be discharged on Day 17 after all scheduled study procedures have been completed If necessary subjects will receive a telephone follow-up 2 days post discharge for documentation of any adverse event or concomitant medication
SafetyPharmacokinetics and Efficacy will be evaluated
In this study 2 cohorts N24 12 subjects for each cohort the doses of which are 296 mgadministration Cohort M1 and 414 mgadministration Cohort M2 are planned Each cohort will enroll approximately equal numbers of male and female subjects The administration area is set as 450 cm2 both feet Each subject will be administered a single dose of YJ001 as multiple sprays 16 spraysfoot for Cohort M1 and 12 spraysfoot for Cohort M2 topically on both feet and below the ankle in the morning on Day 1 and Day 2 and will be administered as twice daily doses once in the morning and the other in the evening with an interval of 11 to 13 h from Day 3 through Day 11
Each cohort will consist of 12 subjects 10 active 2 placebo with approximately equal numbers of male and female subjects
Each cohort will be evaluated separately for safety and PK to allow for dose escalation based on stopping criteria per protocol The Safety Review Committee SRC comprised of the Principal Investigator Medical Monitor and Sponsors qualified designee will convene after completion of each cohort to evaluate available safety PK and other relevant data The decision whether to escalate the dose will be made for a completed cohort based on available safety data through Day 17 5 days post the last dose and blinded PK data maximum observed plasma concentration Cmaxss and area under the concentration-time curve through the first 48 hours post the last dose AUC0-48hss The SRC will determine whether to proceed to the next planned dose level continue with the study and add additional safety evaluations expand the number of subjects at the current level reduce the dose or stop the study
Subjects will be screened between Day -28 through Day -7 rate the scores on Numeric Rating Scale NRS twice daily once in the morning and the other in the evening from Day -7 to Day -1 and will be admitted to the clinic on Day-1 Subjects will be housed within the clinic from Day -1 through Day 17 and will be discharged on Day 17 after all scheduled study procedures have been completed If necessary subjects will receive a telephone follow-up 2 days post discharge for documentation of any adverse event or concomitant medication
SafetyPharmacokinetics and Efficacy will be evaluated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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