CompletedPhase 1
A Phase 1 Study of ABC008 in Ascending (Single Ascending Dose/Multiple Ascending Dose) Study in Patients With (IBM)
Key facts
- Who runs it
- Abcuro, Inc.
- Where
- Australia4 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- Phase
- Phase 1
- People taking part
- 19 people enrolled
- Started
- 25 May 2021
- Ended
- 10 Jan 2025
- Type of study
- Interventional, 9 groups
- Treatments tested
- ABC008
- Record updated
- 20 February 2025
Who can take part
- Age
- 40 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 4 criteriaShow less
Who can take part
- 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
Who cannot take part
- Taking > 7.5 mg prednisolone (or equivalent) or on intravenous immunoglobulin (IVIg) or other immunosuppressants within the last 3 months. Topical, nasal, and ocular corticosteroids are allowed unless they are being widely applied or the severity of the underlying condition makes them unsuitable in the Investigator's opinion. Local steroid injections are allowed
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
An open-label, ascending dose study for adult patients with Inclusion Body Myositis (IBM).
The 9 groups in the trial
- Cohort D1Treatment being tested
Single Dose 0.1 mg / kg ABC008
Treatment: ABC008
- Cohort D2Treatment being tested
Single Dose 0.5 mg / kg ABC008
Treatment: ABC008
- Cohort D3Treatment being tested
Single Dose 2.0 mg / kg ABC008
Treatment: ABC008
- Cohort D4Treatment being tested
Single Dose 5.0 mg / kg ABC008
Treatment: ABC008
- Cohort D5Treatment being tested
X.X mg / kg ABC008
Treatment: ABC008
- Cohort 6Treatment being tested
Single 2.0 mg / kg ABC008
Treatment: ABC008
- MAD Phase Cohort 1Treatment being tested
Multiple Dose 0.1 mg / kg ABC008 every 8 weeks
Treatment: ABC008
- MAD Phase Cohort 2Treatment being tested
Multiple Dose 0.5 mg / kg ABC008 every 8 weeks
Treatment: ABC008
- MAD Phase Cohort 3Treatment being tested
Multiple Dose 2.0 mg / kg ABC008 every 8 weeks
Treatment: ABC008
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Phase 1, Open-Label, Single and Multiple Ascending Dose Study of ABC008 in Adult Patients With Inclusion Body Myositis (IBM)
- Record updated
- 20 February 2025