Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000969-21 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IdeS | Experimental | Intravenous infusion |
|
| PBS Buffer | Placebo Comparator | Intravenous infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IdeS | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety as measured by adverse events | 64 days |
| Measure | Description | Time Frame |
|---|---|---|
| Peak plasma concentration of IdeS | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Total IgG concentration | 64 days |
Inclusion Criteria:
Exclusion Criteria:
Clinically significant disease
Positive HIV, hepatistis B or C
Smoking
Use of medication except paracetamol
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ulf Malmqvist, MD, PhD | Clinical Trial Unit, SUS, Lund, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Unit, FoU centrum Skåne, Skåne University hospital | Lund | 22185 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26177518 | Derived | Winstedt L, Jarnum S, Nordahl EA, Olsson A, Runstrom A, Bockermann R, Karlsson C, Malmstrom J, Palmgren GS, Malmqvist U, Bjorck L, Kjellman C. Complete Removal of Extracellular IgG Antibodies in a Randomized Dose-Escalation Phase I Study with the Bacterial Enzyme IdeS--A Novel Therapeutic Opportunity. PLoS One. 2015 Jul 15;10(7):e0132011. doi: 10.1371/journal.pone.0132011. eCollection 2015. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|