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A Phase 1 Study of ABC008 in Ascending (Single Ascending Dose/Multiple Ascending Dose) Study in Patients With (IBM)

Inclusion Body Myositis Clinical Trial

Official title:
A Phase 1, Open-Label, Single and Multiple Ascending Dose Study of ABC008 in Adult Patients With Inclusion Body Myositis (IBM)

Clinical Trial Summary

An open-label, ascending dose study for adult patients with Inclusion Body Myositis (IBM).

Clinical Trial Description

Participants who successfully complete the SAD EOT visit, and have no emerging safety issues, will be eligible to enroll in Part 2 (MAD). Eligible participants for the MAD part will have inclusion and exclusion criteria (same as those for Part 1) reviewed prior to dosing on MAD Day 1. Participants who successfully complete the MAD EOT visit, and have no emerging safety issues, will be eligible to enrol in Part 3, MAD Extension. After the final MAD visit (W48), participants will have the option to continue on to Part 3 MAD Extension. For Part 3 (MAD Extension), participant dosing will be at 8-week intervals starting at Day 1. Duration of dosing in Part 3 will be up to approximately 80 weeks (18 months), or until a new long-term extension study has been initiated. The SMC will review all participant safety data approximately every 6 months while the Part 3 dosing continues. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04659031
Study type Interventional
Source Abcuro, Inc.
Contact
Status Active, not recruiting
Phase Phase 1
Start date May 25, 2021
Completion date August 2025
View Details
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