Ignite Creation Date:
2024-05-06 @ 3:03 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04502901
Status:
COMPLETED
Last Update Posted:
2021-08-11
First Post:
2020-07-31
Brief Title:
the Safety Tolerability and PK of KX-826 in Healthy Males With Alopecia Following Topical Multiple Dose Ascending
Sponsor:
Suzhou Kintor Pharmaceutical Inc
Organization:
Suzhou Kintor Pharmaceutical Inc
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Parallel Group Dose Escalation Study in Healthy Male Subjects With Androgenetic Alopecia to Evaluate the Safety Tolerability and PK of KX-826 Following Topical Multiple Dose Ascending
Status:
COMPLETED
Status Verified Date:
2021-08
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:
The study is a randomized double-blind placebo-controlled dose-escalation study to evaluate the safety tolerability and PK of KX-826 following topical multiple ascending dose administration
Detailed Description:
KX-826 topical solution will be applied to the scalp of healthy male subjects with androgenetic alopecia
A total of 40 subjects will be evaluated with 32 subjects randomized to receive active drug and 8 subjects randomized to receive placebo in a double-blind fashion 10 subjects in each dose cohort with 8 subjects randomized to receive active drug and 2 subjects randomized to receive placebo for a total of 4 dose cohorts
Cohort Dose of KX-826 Subjects
1 25 mg QD for 14 days 10 8 active 2 placebo
2 5 mg QD for 14 days 10 8 active 2 placebo
3 10 mg QD for 14 days 10 8 active 2 placebo
4 20 mg QD for 14 days 10 8 active 2 placebo
Dose escalation will not occur until review of the multiple dose safety from the previous dose cohort is completed Safety assessments will include monitoring of AEs vital signs blood pressure pulse rate respiratory rate and oral temperature clinical laboratory findings 12-lead ECGs skin irritation assessments and physical examination findings
A total of 40 subjects will be evaluated with 32 subjects randomized to receive active drug and 8 subjects randomized to receive placebo in a double-blind fashion 10 subjects in each dose cohort with 8 subjects randomized to receive active drug and 2 subjects randomized to receive placebo for a total of 4 dose cohorts
Cohort Dose of KX-826 Subjects
1 25 mg QD for 14 days 10 8 active 2 placebo
2 5 mg QD for 14 days 10 8 active 2 placebo
3 10 mg QD for 14 days 10 8 active 2 placebo
4 20 mg QD for 14 days 10 8 active 2 placebo
Dose escalation will not occur until review of the multiple dose safety from the previous dose cohort is completed Safety assessments will include monitoring of AEs vital signs blood pressure pulse rate respiratory rate and oral temperature clinical laboratory findings 12-lead ECGs skin irritation assessments and physical examination findings
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