Trials / Completed
CompletedNCT03272269
Study of IMCY-0098 in Patients With Recent Onset Type 1 Diabetes
A Phase I Placebo-controlled, Double-blind, Dose Escalation Clinical Trial to Evaluate the Safety and Immune Responses of Imcyse's IMCY-0098 in Patients With Recent Onset Type 1 Diabetes
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 41 (actual)
- Sponsor
- Imcyse SA · Industry
- Sex
- All
- Age
- 18 Years – 30 Years
- Healthy volunteers
- Not accepted
Summary
This clinical study will evaluate the safety of an innovative approach expected to be disease-modifying by stopping the auto-immune-mediated destruction of islet β-cells in the pancreas. Three doses of the investigational product will be tested in successive cohorts. Although safety is the first objective of this study, we will gather efficacy data and perform a set of immunological tests to further understand the mechanism of action of this new approach in young adults with recent onset type 1 diabetes.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | IMCY-0098 | Small synthetic peptide for SC admin. Solvent: alum hydroxide |
| OTHER | Placebo | Solvent: alum hydroxide |
Timeline
- Start date
- 2017-08-23
- Primary completion
- 2019-04-17
- Completion
- 2019-08-30
- First posted
- 2017-09-05
- Last updated
- 2019-09-06
Locations
17 sites across 7 countries: Belgium, Denmark, France, Germany, Lithuania, Sweden, United Kingdom
Source: ClinicalTrials.gov record NCT03272269. Inclusion in this directory is not an endorsement.