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

NCT ID: NCT05574543

Last Updated: 2022-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2022-07-13

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.

Conditions

Degenerative Disc Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

0.25 mg AGA111

0.25 mg AGA111 in autologous blood coagulum (ABC) is locally delivered at the intervertebral space.

Group Type: EXPERIMENTAL

AGA111

Intervention Type: DRUG

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

0.5 mg AGA111

0.5 mg AGA111 in ABC is locally delivered to the participants at the intervertebral space.

Group Type: EXPERIMENTAL

AGA111

Intervention Type: DRUG

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

Placebo

Placebo in ABC is locally delivered at the intervertebral space.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

AGA111

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Angitia Biopharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Angitia Medical Director

Role: STUDY_DIRECTOR

Angitia Medical Director

Locations

Beijing Jishuitan Hospital

Beijing, Beijing Municipality, China

Peking University Third Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Countries

China

Other Identifiers

ACT19001

Identifier Type: -

Identifier Source: org_study_id