AP-011 Study to Evaluate the Safety of a Single Intra-articular Injection of Ampion™ for Arthritis of the Basal Thumb Joint

A prospective phase I study to evaluate the safety of a single intra-articular injection of Ampion™ as a treatment for arthritis of the basal thumb joint.

Primary Objective is:

To evaluate the safety of Ampion™ (up to 3 mL) in comparison to saline placebo (up to 3 mL) when injected into the basal thumb joint.

Inclusion criteria

• Able to provide written informed consent to participate in the study.
• Willing and able to comply with all study requirements and instructions of the site study staff.
• Male or female, 40 years to 85 years old (inclusive).
• Radiographic evidence of Basal joint arthritis (Eaton-Littler classification, stages 1 through 4).
• Pain associated with basal joint arthritis, defined as a score ≥ 4 as evaluated by the Australian-Canadian OA Index (AUSCAN)-numeric rating score (NRS, 0-10).

Exclusion criteria

• As a result of medical review and screening investigation, the Principal Investigator considers the subject unfit for the study.
• Previous Ampion™ injection.
• A history of allergic reactions to human albumin (reaction to non-human albumin such as egg albumin is not an exclusion criterion).
• A history of allergic reactions to excipients in 5% human albumin (N-acetyltryptophan, sodium caprylate).
• Women who are currently pregnant or who could become pregnant.
• Inflammatory or crystal arthropathies, acute fractures, history of aseptic necrosis, as assessed locally by the Principal Investigator.
• Any other disease or condition interfering with the free use and evaluation of the index thumb for the duration of the trial (e.g., congenital defects, stricture).
• Major injury to the index thumb within the 12 months prior to screening.
• Any pharmacological or non-pharmacological treatment targeting OA started or changed during the 4 weeks prior to treatment or likely to be changed during the duration of the study.
• Use of the following medications are exclusionary:

• IA injected pain medications in the study thumb during the study;
• Analgesics containing opioids;
• NSAIDs (including but not limited to ibuprofen, aspirin, naproxen, diclofenac) acetaminophen is available as a rescue medication during the study from the provided supply;
• Topical prescription treatment on osteoarthritis index thumb during the study;
• Significant anticoagulant therapy (e.g., Heparin or Lovenox) during the study (treatment such as Aspirin in the cardio-protective dose (81mg) and Plavix are allowed);
• Systemic treatments that may interfere with safety or efficacy assessments during the study;
• Immunosuppressants;
• Use of corticosteroids > 10 mg prednisolone equivalent per day (if ≤ 10 mg prednisolone, the dose must be stable, defined as chronic use of the same dose for at least 1 month).
• Any human albumin treatment in the 3 months before randomization.