A Phase 1 Study of ABC008 in Ascending (Single Ascending Dose/Multiple Ascending Dose) Study in Patients with (IBM)
Recruiting in Palo Alto (17 mi)
+3 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Waitlist Available
Sponsor: Abcuro, Inc.
No Placebo Group
Trial Summary
What is the purpose of this trial?
An open-label, ascending dose study for adult patients with Inclusion Body Myositis (IBM).
Eligibility Criteria
Inclusion Criteria
Diagnosis of either clinico-pathologically defined IBM, clinically defined IBM, or probable IBM according to the European Neuromuscular Center (ENMC) IBM 2011
Able to arise from a chair (with or without armrests) without support from another person or device
Able to ambulate at least 20 feet / 6 meters with or without assistive device
Treatment Details
Interventions
- ABC008 (Other)
Participant Groups
9Treatment groups
Experimental Treatment
Group I: MAD Phase Cohort 3Experimental Treatment1 Intervention
Multiple Dose 2.0 mg / kg ABC008 every 8 weeks
Group II: MAD Phase Cohort 2Experimental Treatment1 Intervention
Multiple Dose 0.5 mg / kg ABC008 every 8 weeks
Group III: MAD Phase Cohort 1Experimental Treatment1 Intervention
Multiple Dose 0.1 mg / kg ABC008 every 8 weeks
Group IV: Cohort D5Experimental Treatment1 Intervention
X.X mg / kg ABC008
Group V: Cohort D4Experimental Treatment1 Intervention
Single Dose 5.0 mg / kg ABC008
Group VI: Cohort D3Experimental Treatment1 Intervention
Single Dose 2.0 mg / kg ABC008
Group VII: Cohort D2Experimental Treatment1 Intervention
Single Dose 0.5 mg / kg ABC008
Group VIII: Cohort D1Experimental Treatment1 Intervention
Single Dose 0.1 mg / kg ABC008
Group IX: Cohort 6Experimental Treatment1 Intervention
Single 2.0 mg / kg ABC008
Find a Clinic Near You
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Who Is Running the Clinical Trial?
Abcuro, Inc.Lead Sponsor