A phase 1, randomised, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of Ent001 in healthy subjects
- Conditions
- type 1 diabetes and inflammatory bowel disease (ulcerative colitis)1001796910012653
- Registration Number
- NL-OMON51546
- Lead Sponsor
- Enthera S.r.l.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To evaluate the safety and tolerability of single ascending doses (SAD) of<br /><br>Ent001 in adult healthy male and female subjects</p><br>
- Secondary Outcome Measures
Name Time Method <p>To evaluate the pharmacokinetics (PK) of SAD of Ent001 in adult healthy male<br /><br>and female subjects<br /><br><br /><br>To assess the presence of antidrug antibodies (ADAs) against Ent001 following<br /><br>SAD of Ent001 in adult healthy male and female subjects</p><br>