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

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.

Conditions

• Arthritis, Rheumatoid

Interventions

DRUG

Tc99m-tilmanocept

Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.

PROCEDURE

SPECT Imaging (60 Minutes post-injection)

Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection.

PROCEDURE

SPECT Imaging (180 Minutes post-injection)

Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection.

PROCEDURE

Whole body planar SPECT imaging (15 Minutes post-injection)

Subjects enrolled in Groups 10-11 will receive a whole body planar SPECT scan performed 15 minutes post-injection for dosimetry.

PROCEDURE

Whole body planar SPECT imaging (60 Minutes post-injection)

Subjects enrolled in Groups 10-11 will receive a whole body planar SPECT scan performed 60 minutes post-injection for dosimetry.

PROCEDURE

Whole body planar SPECT imaging (180 Minutes post-injection)

Subjects enrolled in Groups 10-11 will receive a whole body planar SPECT scan performed 180 minutes post-injection for dosimetry.

PROCEDURE

Whole body planar SPECT imaging (18-20 Hours post-injection)

Subjects enrolled in Groups 10-11 will receive a whole body planar SPECT scan performed 18-20 Hours post-injection for dosimetry.

PROCEDURE

Blood Collection for PK Testing (15 Mins Before Injection)

Blood will be collected for subjects enrolled in Groups 10-11 for the purpose of PK analysis within 15 minutes prior to administration of Tc 99m tilmanocept

PROCEDURE

Blood Collection for PK Testing (after injection)

Blood will be collected for subjects enrolled in Groups 10-11 for the purpose of PK analysis immediately following administration of Tc 99m tilmanocept (00:00)

PROCEDURE

Blood Collection for PK Testing (15 minutes post injection)

Blood will be collected for subjects enrolled in Groups 10-11 for the purpose of PK analysis at 15 ± 5 minutes post injection of Tc 99m tilmanocept

PROCEDURE

Blood Collection for PK Testing (60 minutes post injection)

Blood will be collected for subjects enrolled in Groups 10-11 for the purpose of PK analysis at 60 ± 15 minutes post injection of Tc 99m tilmanocept

PROCEDURE

Blood Collection for PK Testing (180 minutes post injection)

Blood will be collected for subjects enrolled in Groups 10-11 for the purpose of PK analysis at 180 ± 15 minutes post injection of Tc 99m tilmanocept

PROCEDURE

Blood Collection for PK Testing (18-20 hours post injection)

Blood will be collected for subjects enrolled in Groups 10-11 for the purpose of PK analysis at 18-20 hours post injection of Tc 99m tilmanocept

PROCEDURE

Planar Image with both Hands in Field of View

Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection.

Sponsors & Collaborators

• Navidea Biopharmaceuticals

  lead INDUSTRY

Principal Investigators

• Micheal Blue, MD · Navidea Biopharmaceuticals

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-01-31

Primary Completion

2018-06-30

Completion

2018-06-30

Countries

• United States

Study Locations