NCT04483297

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

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Asahi Kasei Therapeutics Corporation · Industry
• Sex: All
• Age: 22 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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)).

Conditions

• Degenerative Spondylolisthesis
• Spinal Stenosis

Interventions

Type	Name	Description
DRUG	AK1320 MS	AK1320 MS + Local Autologous Bone + Posterior Fixation. Ascending Dose.
OTHER	Control	Local Autologous Bone + Posterior Fixation

Timeline

• Start date: 2020-11-18
• Primary completion: 2023-11-27
• Completion: 2024-01-30
• First posted: 2020-07-23
• Last updated: 2024-03-06

Locations

7 sites across 1 country: Canada