A Phase 1 interventional study of AMT-101 and Placebos in Ulcerative Colitis, sponsored by Applied Molecular Transport. Completed at 4 sites in 4 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-28.
Sponsored by Applied Molecular Transport · Phase 1, Interventional, and Treatment
A randomized, double-blind placebo-controlled first in human study in approximately 36 male healthy subjects and approximately 20 male and female patients with active UC who have had an inadequate response to or demonstrated intolerance to 5-ASA.
A randomized, double-blind placebo-controlled first in human study in approximately 36 male healthy subjects and approximately 20 male and female patients with active UC who have had an inadequate response to or demonstrated intolerance to 5-ASA.
Subjects may but are not required to have been exposed to corticosteroids, or immunosuppressive agents. In case the subject has been exposed to any of these treatments, he/she must have had either an inadequate response, failed response or demonstrated intolerance.
Patients may be
1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.
This study's enrollment of 52 is below the median of 60 across 771 interventional studies indexed under Colitis.
Browse Colitis studies →Applied Molecular Transport is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
PART A (Healthy Volunteers)
PART B (Adult Ulcerative Colitis)
Exclusion Criteria:
PART A and PART B
PART B
AMT-101
Drug: AMT-101
Placebo
Drug: Placebos
Single or daily dosing at doses A, B, C, D, E, F
Also known as: no other name applicable
Single or daily dosing at doses A, B, C, D, E, F
Also known as: no other name applicable
Incidence of Treatment-emergent adverse events (safety and tolerability)
Single and multiple ascending doses of AMT-101 in healthy adult volunteers and patients with active UC by evaluation of incidence of treatment-related adverse events as assessed by CTCAE v4.03 and Modified Mayo Score criteria.
Time frame: 14 days
Maximum plasma concentration (CMax)
To assess the pharmacokinetics of AMT-101 and Total IL-10 in healthy volunteers and subjects with UC.
Time frame: 14 days
Pharmacodynamics
To assess plasma IL-1Ra concentration in healthy volunteers and subjects with UC.
Time frame: 14 days
Incidence of anti-drug antibodies against AMT-101
Incidence of anti-drug antibodies against AMT-101 in healthy adult volunteers and subjects with UC.
Time frame: 14 days
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Applied Molecular Transport