11-HMedIdeS-01
10 evidence topics · 1 source
Objective
First-in-human objective
Location and study date
Study design
Allocation and masking
Eligibility criteria
Healthy-volunteer population
Treatment
Phase 1 study in healthy subjects: NCT01802697
Study outcomes
Rationale for using safety and tolerability as the primary endpoint
Not applicable.
Statistical analysis description
Number of participants (Planned and analyzed)
Description of analysis sets
Results
Participant disposition
No evidence found.
Baseline characteristics
No evidence found.
Efficacy results
Phase 1 pharmacodynamic response
Health-related quality of life and patient-reported outcomes
No evidence found.
Safety results
Serious adverse events
Study limitations
Summary
The trial included 29 healthy male participants, with 20 receiving IdeS and 9 receiving placebo. No formal power calculation was performed. Although the study reported no serious adverse events, its small healthy-volunteer population does not establish safety or efficacy in highly sensitized kidney transplant candidates receiving concomitant immunosuppression.