None listed
Conditions
Brief summary
This a randomized, double-blind, placebo-controlled, multiple ascending dose study to evaluate the safety and tolerability in patients with celiac disease who are on a gluten-free diet.
Interventions
The study will consist of a Screening Period, Treatment Period, and a Follow-up Period. Escalating dose cohorts will receive active (12 patients per cohort) or placebo given intradermally in a 2:1 ratio. Patients will receive the same dose for the whole Treatment period. During the Screening period medical history, physical examination, vital sign measurements, ECG, and laboratory assessment will be performed as safety assessments. These assessments will also be performed during the study. Adver
The study will consist of a Screening Period, Treatment Period, and a Follow-up Period. Escalating dose cohorts will receive active (12 patients per cohort) or placebo given intradermally in a 2:1 ratio. Patients will receive the same dose for the whole Treatment period. During the Screening period medical history, physical examination, vital sign measurements, ECG, and laboratory assessment will be performed as safety assessments. These assessments will also be performed during the study. Adverse events and concomitant medications will be assessed from the Screening visit until the end of the study.
Sponsors
ImmusanT, Inc
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Diagnosis of Celiac Disease
Exclusion criteria
Patient has not been prescribed and/or has not followed a GFD for at least 12 months.
Outcome results
None listed