NCT04502901

the Safety, Tolerability and PK of KX-826 in Healthy Males With Alopecia Following Topical Multiple Dose Ascending

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Suzhou Kintor Pharmaceutical Inc, · Industry
• Sex: Male
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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. 2.5 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.

Conditions

• Androgenetic Alopecia

Interventions

Type	Name	Description
DRUG	KX0826	investigational AR antagonist
OTHER	Placebo	Placebo of KX-826

Timeline

• Start date: 2020-01-14
• Primary completion: 2020-08-11
• Completion: 2021-01-15
• First posted: 2020-08-06
• Last updated: 2021-08-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study