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First-In-Human Study of AK1320 Encapsulated Microspheres (AK1320 MS) — ENHANCE  

Spinal Stenosis Clinical Trial

Official title:
First-In-Human Study of AK1320 Encapsulated Microspheres (AK1320 MS) In Subjects With Degenerative Spondylolisthesis and Concomitant Symptomatic Spinal Stenosis Who Are Undergoing Decompression And Single Level Instrumented Posterolateral Lumbar Autograft Fusion Surgery

Clinical Trial Summary

The safety and efficacy of AK1320 MS will be evaluated in patients with degenerative spondylolisthesis and concomitant symptomatic spinal stenosis who are undergoing decompression and single level instrumented posterolateral lumber autograft fusion surgery.

Clinical Trial Description

This will be a first in human Phase I, ascending dose, multi-center, randomized patient study evaluating the efficacy, safety, PK of AK1320 MS. The study will enroll up to 4 dose escalating cohorts with each cohort having 2 treatment groups. Cohort 1 and Cohort 2 (AK1320 MS group (n=3-7); Control group (n=0-3)) and Cohort 3 and Cohort 4 (AK1320 MS group (n=6-7); Control group (n=0-3)). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04483297
Study type Interventional
Source Asahi Kasei Pharma Corporation
Contact
Status Terminated
Phase Phase 1
Start date November 18, 2020
Completion date January 30, 2024
View Details
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