NCT03371420

PET Imaging of Subjects Using 124I-PU-AD

PET Imaging of Subjects Using 124I-PU-AD: A Pilot Study

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Samus Therapeutics, Inc. · Industry
• Sex: All
• Age: 21 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This is a first in-human, open-label pilot (microdose) study of the positron-emitting agent 124I-PU-AD in subjects with specific cancer types (solid malignancy, lymphoma, and/or myeloma) and/or Alzheimer's disease.

Detailed description

This first in-human trial of the positron-emitting agent 124I-PU-AD is an open-label pilot (microdose) study. Up to 10 evaluable subjects who have active disease will be enrolled to evaluate the PK, metabolism, biodistribution, and radiation dosimetry of 124I-PU-AD. Following a 28-day screening period, eligible subjects will return to the clinic on Day 1. A single dose of 124I-PU-AD will be administered by intravenous (IV) injection to subjects. After 124I-PU-AD tracer injection, PET scans will be performed at 4 time points. At each time-point, an axial body image is acquired on a state-of-the-art PET-CT scanner. A low-dose CT will be obtained immediately-prior to PET imaging, at each time-point. Serial blood samples will also be obtained at multiple time points. Subjects will be evaluated to ensure that there are no clinically significant ongoing AEs prior to discharge.

Conditions

• Lymphoma
• Solid Malignancy
• Alzheimer Disease
• Myeloma

Interventions

Type	Name	Description
DRUG	PU-AD
DEVICE	PET Scan
OTHER	Blood Draws

Timeline

• Start date: 2016-04-01
• Primary completion: 2019-06-10
• Completion: 2019-06-10
• First posted: 2017-12-13
• Last updated: 2023-04-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study