At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 23 enrolled
Drug / intervention
TIMP-GLIAdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1, First-in-Human, 2-Part, Multicenter Dose Escalation and Repeat Dose Study of the Safety, Tolerability and Pharmacokinetics of TIMP-GLIA in Subjects With Celiac Disease
In Brief
A Phase 1 clinical trial evaluating TIMP-GLIA for Celiac Disease. Completed, enrolled 23 participants across 4 sites.
Detailed Summary
This study is to characterize the safety and tolerability of an investigational drug called TIMP-GLIA when either one or two intravenous doses are given to subjects with celiac disease. The way the body reacts to TIMP-GLIA is being checked by laboratory tests of the blood and urine, and study subject health will also be monitored by vital signs such as blood pressure, electrocardiogram (ECG), and physical examination.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCeliac Disease
CountriesUnited States
CollaboratorsCOUR Pharmaceutical Development Company, Inc.
Timeline
Phase 1CompletedFinished
201820192020202120222023202420252026
Enrollment StartJan 2018
First PostedApr 2018
Primary CompletionMay 2019
Study CompletionJul 2019
TodayJul 2026
First PostedApr 3, 2018
Enrollment StartJan 23, 2018
Primary CompletionMay 24, 2019
Study CompletionJul 22, 2019
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 8.2 years ago
Interventions
TIMP-GLIAdrug
intravenous infusion.