An open label positron emission tomography (PET) imaging study using 89-Zirconium labelled GSK3128349 to investigate the biodistribution and clearance of an albumin binding domain<br>antibody (AlbudAb) GSK3128349 following single dose intravenous administration in healthy male subjects.

Completed

• Conditions: niet van toepassing; not applicable

• Registration Number: NL-OMON42953
• Lead Sponsor: GlaxoSmithKline Research & Development Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 8

Inclusion Criteria

healthy male subjects
50 - 65 years of age, inclusive
BMI 19.0 - 31.0 kilograms/meter2
non smokers or less than 5 cigarettes per day

Exclusion Criteria

Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Evaluate biodistribution of 89Zr-GSK3128349 in regions of interest following IV<br /><br>administration to support future AlbudAb products and the development of a PBPK<br /><br>model.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Measure PK of 89Zr-GSK3128349 by whole blood, plasma and urine radiolabel<br /><br>detection to support future AlbudAb products and the<br /><br>development of a PBPK model.<br /><br><br /><br>Measure PK of GSK8128349 by mass spectroscopy (MS) to support the development<br /><br>of a PBPK model.<br /><br><br /><br>Measure dosimetry of 89Zr-GSK3128349 from PET scans and blood radioactivity.<br /><br><br /><br>Assess the safety and tolerability of 89Zr-GSK3128349.<br /><br><br /><br>Investigate the presence and levels of anti-GSK3128349 antibodies, including<br /><br>pre and post-dose.</p><br>