A Study to Evaluate XTR006 in Chinese Volunteers

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Alzheimer Disease

Clinical Trial Details

NCT number	NCT06151795
Study type	Interventional
Source	Sinotau Pharmaceutical Group
Contact
Status	Completed
Phase	Phase 1
Start date	June 12, 2023
Completion date	January 10, 2024

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