[Phase I clinical study for 111In-DTPA-IgG]

Area of Science:

• Nuclear Medicine
• Radiopharmaceutical Development
• Clinical Trials

Background:

• Inflammation and infection imaging agents are crucial for diagnosis.
• 111In-DTPA-IgG is a novel agent developed for improved detection.
• Phase I studies are essential to establish safety and preliminary biodistribution.

Purpose of the Study:

• To evaluate the safety and tolerability of 111In-DTPA-IgG in healthy volunteers.
• To determine the biodistribution and pharmacokinetic profile of 111In-DTPA-IgG.
• To estimate radiation dosimetry for safe administration in future studies.

Main Methods:

• A single-center, open-label, phase I clinical trial.
• Inclusion of three healthy adult volunteers.
• Administration of a single dose of 111In-DTPA-IgG followed by safety assessments and biodistribution imaging.

Main Results:

• No adverse events were reported, with no significant changes in clinical laboratory parameters, vital signs, or physical examinations.
• 111In-DTPA-IgG exhibited biexponential clearance from blood with half-lives of approximately 5.72–8.51 hours (fast phase) and 34.0–35.5 hours (slow phase).
• Urinary excretion accounted for 12% of the injected dose within 72 hours. Dosimetry estimates suggest up to 80 MBq can be safely administered, with the liver, kidneys, heart, and lungs receiving the highest absorbed doses (<40 mGy per 80 MBq).

Conclusions:

• 111In-DTPA-IgG demonstrates a favorable safety profile and predictable biodistribution in healthy volunteers.
• Radiation dosimetry supports the safe administration of 111In-DTPA-IgG for scintigraphic imaging of inflammation/infection.
• The findings support the progression to phase II clinical studies to further evaluate the efficacy of 111In-DTPA-IgG.