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A Phase I/II Study of AGA111 for Lumbar Interbody Fusion in Patients With Degenerative Disc Disease

NCT05574543 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-10-10

No results posted yet for this study

Summary

The objectives of the study are to evaluate the safety and preliminary efficacy of a single administration of AGA111 for lumbar interbody fusion in patients with degenerative disc disease.

Conditions

  • Degenerative Disc Disease

Interventions

DRUG

AGA111

AGA111 is locally administered in an ABC carrier at the intervertebral space during the lumbar interbody fusion.

DRUG

Placebo

Placebo is locally administered in an ABC carrier at the intervertebral space during the lumbar interbody fusion.

Sponsors & Collaborators

  • Angitia Biopharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Angitia Medical Director · Angitia Medical Director

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2022-07-13
Completion
2022-07-13

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05574543 on ClinicalTrials.gov