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

Asahi Kasei Medical

Status and phase: Terminated; Phase 1

Conditions: Spinal Stenosis; Degenerative Spondylolisthesis

Treatments: Drug: AK1320 MS; Other: Control

Study type: Interventional

Funder types: Industry

Identifiers

NCT04483297

AK1320-101

Details and patient eligibility

About

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.

Full 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)).

Enrollment: 30 patients

Sex: All

Ages: 22 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Involved level L1 to S1
2. Use of local autologous bone only.
3. Degenerative spondylolisthesis up to Meyerding's Classification Grade 1 or 2.
4. Moderate or higher disability as assessed by Oswestry Disability Index.
5. Neurogenic claudication and/or radiculopathy with or without back pain.
6. Male or female over 22 years of age and less than 81 years of age.

Exclusion criteria

1. Prior lumbar decompression or spine fusion attempt (any level).
2. Undergoing concurrent interbody fusion.
3. Requires spinal fusion at more than one lumbar level.
4. Degenerative scoliosis.
5. BMI > 40.
6. Radiographically confirmed significant spinal instability.
7. Active or recent (within the past two (2) years) worker's compensation litigation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

AK1320 MS

Experimental group

Description:

AK1320 MS + Local Autologous Bone + Posterior Fixation

Treatment:

Drug: AK1320 MS

Control

Other group

Description:

Local Autologous Bone + Posterior Fixation

Treatment:

Other: Control