NCT06151795

A Study to Evaluate XTR006 in Chinese Volunteers

A Phase I Study to Evaluate the Safety, Biodistribution, Radiation Dosimetry, and Pharmacokinetics of XTR006 in Healthy Chinese Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Sinotau Pharmaceutical Group · Industry
• Sex: All
• Age: 50 Years – 70 Years
• Healthy volunteers: Accepted

Summary

XTR006 is a 18F-labeled positron emission tomography （PET）tracer for imaging tau protein in the brain. This phase I study investigated the safety, biodistribution, radiation dosimetry and Pharmacokinetics of XTR006 in 10 healthy elderly Chinese volunteers.

Detailed description

XTR006 is a 18F-labeled PET tracer, for the quantification of neurofibrillary tangle (NFT) deposition in the brain. Brain NFT deposition is a pathologic finding in Alzheimer's Disease (AD), with brain NFT density shown to correlate with the severity of cognitive impairment in AD. This Phase I study will be open-labeled, nonrandomized, single center study. Enrolled 10 healthy elderly Chinese volunteers who meet all of the inclusion and none of the exclusion criteria. Subjects will receive 8-10mCi of XTR006 via IV injection. Safety and tolerability will be observed. Biodistribution, pharmacokinetics, and dosimetry will be investigated.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	XTR006	Single dose intravenous injection of XTR006. Serial whole-body PET scan will be obtain after injection, blood and urine collection after injection for the assessment of pharmacokinetics.

Timeline

• Start date: 2023-06-12
• Primary completion: 2023-09-27
• Completion: 2024-01-10
• First posted: 2023-11-30
• Last updated: 2024-05-03

Locations

1 site across 1 country: China