NCT04659031

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Abcuro, Inc. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Inclusion Body Myositis

Interventions

Type	Name	Description
DRUG	ABC008	ABC008

Timeline

• Start date: 2021-05-25
• Primary completion: 2025-01-10
• Completion: 2025-01-10
• First posted: 2020-12-09
• Last updated: 2025-02-20

Locations

4 sites across 1 country: Australia

Regulatory

• FDA-regulated drug study