← Back to Search

Other

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

Phase 1
Waitlist Available
Research Sponsored by Abcuro, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion an average of 28 weeks for sad (single ascending dose) phase and 52 weeks for mad (multiple ascending dose) phase]
Awards & highlights
No Placebo-Only Group

Summary

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

Eligible Conditions
  • Inclusion Body Myositis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion an average of 28 weeks for sad (single ascending dose) phase and 52 weeks for mad (multiple ascending dose) phase]
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion an average of 28 weeks for sad (single ascending dose) phase and 52 weeks for mad (multiple ascending dose) phase] for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Assessment of Safety and Tolerability
Secondary study objectives
Assessment of apparent clearance (CL/F)
Assessment of apparent volume of distribution (Vz/F)
Assessment of area under the concentration versus time curve from time zero to 24 hours post-dose (AUC0-24hr)
+13 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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 Location

Who is running the clinical trial?

Abcuro, Inc.Lead Sponsor
3 Previous Clinical Trials
522 Total Patients Enrolled
~1 spots leftby Mar 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top