Trials / Completed
CompletedNCT01802697
Safety Study on IdeS in Healthy Volounteers
A Phase i Single Center Study to Evalute the Safety, Tolerability and Pharmacokinetics of Intravenous IdeS After Administration of Single Ascending Doses in Healthy Male Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 29 (actual)
- Sponsor
- Hansa Biopharma AB · Industry
- Sex
- Male
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
This is a first in man study to assess safety and tolerability of the IgG cleaving enzyme Immunoglobuli G degrading enzyme of streptococcus pyogenes (IdeS).
Detailed description
A phase I study (11-HMedIdeS-01, EudraCT no. 2012-000 969-21) first in man single ascending dose study in 29 healthy subjects to investigate if IdeS is safe and well tolerated in doses up to 0.24 mg/kg body weight (BW).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | IdeS | |
| DRUG | Placebo |
Timeline
- Start date
- 2013-02-01
- Primary completion
- 2013-12-01
- Completion
- 2014-02-01
- First posted
- 2013-03-01
- Last updated
- 2017-01-19
Locations
1 site across 1 country: Sweden
Source: ClinicalTrials.gov record NCT01802697. Inclusion in this directory is not an endorsement.