type 1 diabetes and inflammatory bowel disease (ulcerative colitis)
Conditions
Interventions
Group Day Treatment How often Dosing form
1 1 Ent001 0.15 mg/kg or placebo Once Infusion into the bloodstream
(intravenous infusion)
2 Ent001 0.5 mg/kg or placebo
3 Ent001 1.7 mg/kg or placebo
4 En
Sponsors
Enthera S.r.l.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Sex: male or female; females must be of nonchildbearing potential or postmenopausal. 2. Age: 18 to 65 years, inclusive, at screening. 3. Body mass index: 18.0 kg/m2 to 30.0 kg/m2, inclusive, at screening. Calculated as body weight (kg) divided by height (m)2. 4. Weight: >=50 kg at screening. 5. Status: healthy subjects. Further criteria apply
Exclusion criteria
Exclusion criteria: 1. Previous participation in the current study. 2. Employee of ICON or the Sponsor. 3. History of sensitivity to any of the study treatments, or components thereof, or any clinically significant history of allergic conditions as judged by the Investigator (including drug allergies, asthma, eczema, or anaphylactic reactions, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing). 4. The subjects who have had a prior allergic reaction, including anaphylaxis, to any other human, humanized, chimeric, or rodent antibodies. 5. Using tobacco products within 3 months prior to dosing. Further criteria apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of single ascending doses (SAD) of Ent001 in adult healthy male and female subjects | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the pharmacokinetics (PK) of SAD of Ent001 in adult healthy male and female subjects To assess the presence of antidrug antibodies (ADAs) against Ent001 following SAD of Ent001 in adult healthy male and female subjects | — |
Countries
Netherlands
Outcome results
None listed