Clinical trial NCT05574543: A Phase I/II Study of AGA111 for Lumbar Interbody Fusion in Patients With Degenerative Disc Disease
Official title: A Randomized, Double-blinded, Placebo-controlled, Phase I/II Study to Evaluate the Safety and Preliminary Efficacy of Single Administration of AGA111 for Lumbar Interbody Fusion in Patients With Degenerative Disc Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Degenerative Disc Disease
Lead sponsor: Angitia Biopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2022-10-10
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Willing and capable of giving signed informed consent.
2. Male or female, age between 40-80 years.
3. Male or female of childbearing potential must agree to use a highly effective contraception throughout the entire study period, and female subjects must have a negative pregnancy test prior to the randomization.
4. Has degenerative disc disease (DDD) of the lumbosacral(L3-S1) spine that results in back pain, with or without radiating leg pain.
5. Has radiographic evidence (e.g. CT, MRI, x-ray, etc.) of degenerative disc disease.
6. Planning to receive single-level lumbar interbody fusion.
7. Willing and capable of adhering to the protocol and visit schedule.

Exclusion Criteria:

1. Prior surgical procedure at the involved or adjacent spinal levels.
2. Presence or prior history of inflammatory disease of the spine.
3. Presence or prior history of neoplastic disease of the spine.
4. BMI \<18.5 or BMI \>35.
5. Documented titanium allergy or intolerance.
6. Presence or prior history of malignancy (except for fully resected basal cell carcinoma of the skin).
7. Presence or history of an uncontrolled, unstable, clinically significant medical condition that, in the opinion of the investigator, could jeopardize or compromise the subject's safety or ability to participate in this study.
8. Active local or systemic infection.
9. Female subject who is pregnant or lactating.
10. Serological evidence of positive human immunodeficiency virus (HIV) antibody.
11. HBsAg positive or HBeAg positive, along with positive HBV DNA test.
12. Serological evidence of HCV antibody, along with HCV RNA \> lower limit of detection.
13. Known drug or alcohol abuser.

Primary outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: Up to 12 months
measure: Number of participants who develop anti-drug antibody to AGA111
timeFrame: Up to 90 days post operation
Secondary outcomes:
measure: Radiographic fusion success
timeFrame: Up to 12 months post operation
measure: New Bone formation
timeFrame: Up to 12 months post operation
measure: Oswestry Disability Index (ODI)
timeFrame: Up to 12 months post operation
measure: Pain score through Visual Analogue Scale (VAS)
timeFrame: Up to 12 months post operation
measure: Maximum Concentration (Cmax) of AGA111
timeFrame: 90 minutes before administration, and 30 minutes, 1 hour, 6 hours, and 24 hours post administration.
measure: Time to maximum concentration (Tmax) of AGA111
timeFrame: 90 minutes before administration, and 30 minutes, 1 hour, 6 hours, and 24 hours post administration.
measure: Area under the concentration time curve (AUC)
timeFrame: 90 minutes before administration, and 30 minutes, 1 hour, 6 hours, and 24 hours post administration.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Jishuitan Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
state: Guangdong
city: Suzhou
country: China
facility: The Second Affiliated Hospital of Soochow University
state: Jiangsu
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
Study officials:
affiliation: Angitia Medical Director
name: Angitia Medical Director
role: STUDY_DIRECTOR
References: