Evaluating Safety of Escalating Doses of Tilmanocept by IV Injection and SPECT Imaging in Subjects With and Without RA

• Status: Completed
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Prospective, open-label, multicenter, dose escalation, safety with pharmacokinetics (PK) and dosimetry study of injected Tc 99m tilmanocept in the detection of and assessment of localization to skeletal joints in subjects with and without active RA by SPECT imaging.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Navidea Biopharmaceuticals

Criteria

Inclusion Criteria:

ALL SUBJECTS:

• The subject has provided written informed consent with HIPAA (Health Information Portability and Accountability Act) authorization before the initiation of any study-related procedures.

• Has a negative urine drug screening for illicit or unprescribed drugs suggestive of drug abuse.

• All subjects shall be ≥18 years of age at the time of consent.

CONTROL SUBJECTS:

• The subject is deemed to be clinically free of any inflammatory disease (s) and has not experienced joint pain for at least 4 weeks prior to the consent date.

ACTIVE RHEUMATOID ARTHRITIS SUBJECTS:

• The subject has moderate to severe RA as determined by the 2010 ACR/EULAR (score of ≥ 6/10).

• The subject has a DAS28 of ≥ 3.2 (includes the Erythrocyte Sedimentation Rate [ESR] test and Visual Analog Scale [VAS]) .

• If the subject is receiving methotrexate, they have been at a stable dose for > 4 weeks prior to the Baseline Visit 2 (Day 1).

• If the subject is receiving biologic therapy, they have been at a stable dose > 8 weeks prior to the Baseline Visit 2 (Day 1).

• If the subject is receiving NSAIDS or oral corticosteroids, the dose has been at a stable dose for > 4 weeks prior to the Baseline Visit 2 (Day 1). The corticosteroid dose should be ≤ 10mg/day of prednisone or an equivalent steroid dose.

Exclusion Criteria:

• The subject is pregnant or lactating.

• The subject size or weight is not compatible with imaging per the investigator.

• The subject has had or is currently receiving radiation therapy or chemotherapy for a condition other than rheumatoid arthritis.

• The subject has renal insufficiency as demonstrated by serum creatinine clearance of < 60 mL/min.

• The subject has hepatic insufficiency as demonstrated by ALT or AST greater than two times the upper limit of normal.

• The subject has a chronic or persistent infection or has any condition that would, in the opinion of the examining physician, preclude their participation.

• The subject has a known allergy to or has had an adverse reaction to dextran exposure.

• The subject has received an investigational product within 30 days prior to the Tc 99m tilmanocept administration.

• The subject has received any radiopharmaceutical within 7 days prior to the administration of Tc 99m tilmanocept.