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

NCT05574543 | Completed Phase 1

• 1 other identifier: ACT19001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 6

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.

Conditions

Degenerative Disc Disease

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Up to 90 days post operation

Secondary Outcomes (7)

• Radiographic fusion success

  Up to 12 months post operation

• New Bone formation

  Up to 12 months post operation

• Oswestry Disability Index (ODI)

  Up to 12 months post operation

• Pain score through Visual Analogue Scale (VAS)

  Up to 12 months post operation

• Maximum Concentration (Cmax) of AGA111

  90 minutes before administration, and 30 minutes, 1 hour, 6 hours, and 24 hours post administration.

Study Arms (3)

0.25 mg AGA111

EXPERIMENTAL

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

Drug: AGA111

0.5 mg AGA111

EXPERIMENTAL

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

Drug: AGA111

Placebo

PLACEBO COMPARATOR

Placebo in ABC is locally delivered at the intervertebral space.

Drug: Placebo

Interventions

AGA111 DRUG

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

0.25 mg AGA111; 0.5 mg AGA111

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and capable of giving signed informed consent.
• Male or female, age between 40-80 years.
• 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.
• Has degenerative disc disease (DDD) of the lumbosacral(L3-S1) spine that results in back pain, with or without radiating leg pain.
• Has radiographic evidence (e.g. CT, MRI, x-ray, etc.) of degenerative disc disease.
• Planning to receive single-level lumbar interbody fusion.
• Willing and capable of adhering to the protocol and visit schedule.

You may not qualify if:

• Prior surgical procedure at the involved or adjacent spinal levels.
• Presence or prior history of inflammatory disease of the spine.
• Presence or prior history of neoplastic disease of the spine.
• BMI \<18.5 or BMI \>35.
• Documented titanium allergy or intolerance.
• Presence or prior history of malignancy (except for fully resected basal cell carcinoma of the skin).
• 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.
• Active local or systemic infection.
• Female subject who is pregnant or lactating.
• Serological evidence of positive human immunodeficiency virus (HIV) antibody.
• HBsAg positive or HBeAg positive, along with positive HBV DNA test.
• Serological evidence of HCV antibody, along with HCV RNA \> lower limit of detection.
• Known drug or alcohol abuser.

Sponsors & Collaborators

• Angitia Biopharmaceuticals: lead

Study Sites (6)

Beijing Jishuitan Hospital

Beijing, Beijing Municipality, 100035, China

Location

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

Location

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

Guangzhou, Guangdong, 510120, China

Location

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215004, China

Location

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Angitia Medical Director

  Angitia Medical Director

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2022
• First Posted: October 10, 2022
• Study Start: December 1, 2020
• Primary Completion: July 13, 2022
• Study Completion: July 13, 2022
• Last Updated: October 10, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)