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

A prospective phase I study to evaluate the safety and efficacy 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.

Secondary objectives are to:

- Evaluate the efficacy of Ampion™ versus saline placebo in decreasing pain when injected
into the basal thumb joint.

- Evaluate the efficacy of Ampion™ versus saline placebo in improving hand function when
injected into the basal thumb joint.

- Evaluate the efficacy of Ampion™ versus saline placebo in improving thumb stiffness
when injected into the basal thumb joint.

- Evaluate the efficacy of Ampion™ versus saline placebo in improving overall global
assessment of disease severity when injected into the basal thumb joint.

Inclusion Criteria:

1. Able to provide written informed consent to participate in the study.

2. Willing and able to comply with all study requirements and instructions of the site
study staff.

3. Male or female, 40 years to 85 years old (inclusive).

4. Radiographic evidence of Basal joint arthritis (Eaton-Littler classification, stages
1 through 4).

5. 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:

1. As a result of medical review and screening investigation, the Principal Investigator
considers the subject unfit for the study.

2. Previous Ampion™ injection.

3. A history of allergic reactions to human albumin (reaction to non-human albumin such
as egg albumin is not an exclusion criterion).

4. A history of allergic reactions to excipients in 5% human albumin
(N-acetyltryptophan, sodium caprylate).

5. Women who are currently pregnant or who could become pregnant.

6. Inflammatory or crystal arthropathies, acute fractures, history of aseptic necrosis,
as assessed locally by the Principal Investigator.

7. 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).

8. Major injury to the index thumb within the 12 months prior to screening.

9. 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.

10. 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).

11. Any human albumin treatment in the 3 months before randomization.