Healthy Clinical Trial - PET Study of Repeated ASN51 in Healthy Volunteers

Status Completed

Clinical Trial Summary

This is a phase 1, open-label, dose escalation, PET study to investigate the brain occupancy of O-GlcNAcase, and the PD response in PBMCs, after repeated doses of ASN51 in healthy subjects.

Clinical Trial Description

The clinical data from the first-in-human single- and multiple-ascending dose study of ASN51 (ASN51-101), and the adaptive-design PET study of O-GlcNAcase brain ASN51 occupancy after single oral doses (ASN51-102), showed acceptable safety, tolerability and PK. However, to date, no assessment of RO after multiple doses of ASN51 and at plasma concentrations below the EC50 have been done. Hence, the purpose of this study is to assess brain O-GlcNAcase RO using PET following repeated doses of ASN51. The study will also characterise the PBMC response (including the effect of food), and further assess the safety, tolerability, PK, and PK/RO relationship, after repeated ASN51 doses. The results of this study will be used to select doses for subsequent studies in patients. ;

Study Design

Related Conditions & MeSH terms

Healthy

Clinical Trial Details

NCT number	NCT05725005
Study type	Interventional
Source	Asceneuron S.A.
Contact
Status	Completed
Phase	Phase 1
Start date	January 26, 2023
Completion date	June 8, 2023

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