A Phase 1/2 interventional study of AGA111 and Placebo in Degenerative Disc Disease, sponsored by Angitia Biopharmaceuticals. Completed at 6 sites in China. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-10-10.
Sponsored by Angitia Biopharmaceuticals · Phase 1/2, Interventional, and Treatment
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.
A randomized, double-blind, placebo-controlled, phase 1/2 study to evaluate the safety and preliminary efficacy of single administration of AGA111 for lumbar interbody fusion in patients with degenerative disc disease. A total of 60 participants will be enrolled and randomized to placebo, AGA111 0.25 mg, or AGA111 0.5 mg at 1: 1: 1 ratio. All participants will undergo lumbar interbody fusion and receive study treatment during the surgery.
472 studies on the registry are indexed under Intervertebral Disc Degeneration; 100 are open to participants now.
This study's enrollment of 60 is close to the median of 60 across 268 interventional studies indexed under Intervertebral Disc Degeneration.
Browse Intervertebral Disc Degeneration studies →Angitia Biopharmaceuticals is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
0.25 mg AGA111 in autologous blood coagulum (ABC) is locally delivered at the intervertebral space.
Drug: AGA111
0.5 mg AGA111 in ABC is locally delivered to the participants at the intervertebral space.
Drug: AGA111
Placebo in ABC is locally delivered at the intervertebral space.
Drug: Placebo
AGA111 is locally administered in an ABC carrier at the intervertebral space during the lumbar interbody fusion.
Placebo is locally administered in an ABC carrier at the intervertebral space during the lumbar interbody fusion.
Number of participants with adverse events (AEs)
An adverse event (AE) is any untoward medical occurrence in clinical study participant, temporally associated with the use of the investigational product (IP), whether or not considered related to the IP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IP.
Time frame: Up to 12 months
Number of participants who develop anti-drug antibody to AGA111
Blood samples taken prior to the operation and 5 days, 28 days and 90 days post operation were tested for anti-AGA111 antibodies using an immunoassay method.
Time frame: Up to 90 days post operation
Radiographic fusion success
Radiographic fusion success is defined as evidence of continuous bone bridging from the superior to the inferior vertebrae via CT evaluation and no evidence of motion as defined by less than 3mm translational motion and less than 5° in angular motion at the treated level via hyperextension and hyperflexion X-rays.
Time frame: Up to 12 months post operation
New Bone formation
New bone formation is defined as the ratio of successful fusion area to the total area in the transverse plane of CT scan.
Time frame: Up to 12 months post operation
Oswestry Disability Index (ODI)
The change of point in ODI from baseline.
Time frame: Up to 12 months post operation
Pain score through Visual Analogue Scale (VAS)
The change of point in VAS from baseline.
Time frame: Up to 12 months post operation
Maximum Concentration (Cmax) of AGA111
Maximum concentration of AGA111 after dosing.
Time frame: 90 minutes before administration, and 30 minutes, 1 hour, 6 hours, and 24 hours post administration.
Time to maximum concentration (Tmax) of AGA111
Time to maximum concentration of AGA111 after dosing.
Time frame: 90 minutes before administration, and 30 minutes, 1 hour, 6 hours, and 24 hours post administration.
Area under the concentration time curve (AUC)
Definite integral of the curve describing the variation of AGA111 in blood as a function of time.
Time frame: 90 minutes before administration, and 30 minutes, 1 hour, 6 hours, and 24 hours post administration.
Plan to share: No
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This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Intervertebral Disc Degeneration →
Angitia Biopharmaceuticals